European Pharmacopoeia

European Pharmacopoeia reference substances and preparations are selected and verified by the EP ... EPA0363000 Amantadine hydrochloride 100 mg...

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European Pharmacopoeia

European Pharmacopoeia Background The European Pharmacopoeia (EP) Commission includes in its membership delegates from nations who have adopted the European Pharmacopoeia. The EP Commission is in charge of judging the suitability of monographs. Prior to release, a new monograph must be adopted by the EP Commission, and then published in the annual ‘Fascicule’. Member States then officially adopt the new monograph on 1st January of the following year. To support the monographs of the European Pharmacopoeia, a collection of reference substances has been made available which includes: 1.

Current, official, European Pharmacopoeia Chemical Reference Substances (EP CRS) and Biological Reference Preparations (BRP)

2.

Reference Spectra

3.

Other reference preparations, including Enzymes and Substrates from the International Commission on Pharmaceutical Enzymes and Certified Viscosity Standards from Van Swinden Laboratories.

4.

With supplement 4.3, the revised EP general method 2.2.6 replaces CRS reference liquids with certified reference materials available from suppliers of chemical reagents or materials certified for metrology. Ten liquid CRMs, certified by the Physical Chemistry Division of the Central Office of Measures (GUM), Warsaw in Poland, cover the wide range of refractive index from 1,333 (water) to 1,657 (1-bromonaphthalene). More detailed information is given in the chapter "Dyes and refractive index CRMs" of this catalogue.

5.

European Pharmacopoeia Reagents.

Relationship with other pharmacopoeias in Europe Any reference substance, spectra or preparation required for a new EP monograph, is made available as soon as the monograph comes into force. Many of the member countries of the European Pharmacopoeia Commission have adopted the EP in full, and their monographs require only EP CRS/BRP. When an EP monograph is adopted by the pharmacopoeia of a member state of the Council of Europe then any reference material that may have been available from a national pharmacopoeia, e.g. BP or PF, will usually be discontinued in favour of the EP reference substance. However, a number of member countries of the EP Commission maintain national pharmacopoeial monographs, especially for finished dosage forms, which require the use of separate reference substances. A separate chapter in this catalogue includes lists of the reference substances produced for the British, French, Swiss and International pharmacopoeia monographs. The International Pharmacopoeia (IP) reference substances are described in the section referring to the WHO (World Health Organization).

Production and certification European Pharmacopoeia reference substances and preparations are selected and verified by the EP laboratories as being suitable for the use as prescribed in the relevant monograph of the European Pharmacopoeia. Since CRS and BRP are officially certified by the European Pharmacopoeia Commission, it should be noted that neither certificates of analysis nor data not relevant to the use of the products as defined by the EP monograph are provided with the reference product or substance.

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

249

European Pharmacopoeia Storage, shelf life and expiry dates and size units European Pharmacopoeia CRS/BRP are subject to regular inspection and repeated analysis by EP scientific staff. Each EP CRS/BRP is, on receipt by the customer, fit for the intended use. No expiry date is indicated on the reference materials because the products or substances comply with the requirements of the corresponding monograph and are monitored regularly. When batches are to be changed, LGC Standards can provide you with the date on which the previous lot will no longer be official. In specific cases for reasons related to filling or labeling, sub-batches are obtained from the same batch of bulk material. However, all the necessary precautions are taken in order to guarantee that the quality and specifications of the sub-batches do not differ from one to another. Please note, that new lots can have different unit sizes, especially with pharmacopoeial reference standards, and LGC Standards is not responsible for such cases. If the unit size of a new batch changes, LGC Standards will provide this information to customers in new lot lists. The EP is also currently over-labelling all its reference standards vials with a secondary label. This new secondary label is useful for customs purposes as it can be peeled off. It can also be stuck onto your laboratory book to prove the use of the reference standard. All the required information to perform the tests described in the European Pharmacopoeia monographs are stated on the primary label. EP recommends only sufficient material should be purchased for immediate use and that unopened vials should be stored in the dark unless otherwise stated. Whilst most EP CRS/BRP can be shipped at ambient temperature, certain items have to be maintained at controlled temperatures at all times and are subject to special shipping charges and storage conditions (details are available on request). Where no drying conditions are stated, the substance is to be used as received. Once opened, EP can no longer guarantee the stability of the material and any of the CRS/BRP not used should be disposed of and not kept for future use.

Validation of secondary standards All secondary in-house working standards have to be validated against the corresponding EP CRS/BRP. Please make sure that the secondary material is used only for the same official purposes for which the primary pharmacopoeial material was designed.

Proper use EP discontinued their use code number system as of January 2006. For information on the use of the substances please refer to the monograph or contact your local LGC Standards office.

Opening For reference substances and preparations supplied in sealed glass ampoules the following technique is suitable for opening the ampoule: tap gently to collect the material at the lower end, score the ampoule with a file, heat a glass rod to white heat and apply firmly to the file mark. If the glass does not crack, deepen and extend the file mark, and repeat the process. Eye and hand protection MUST be used. Many reference substances are supplied as lyophilised material in a septum vial. No attempt should be made to open the vial and weigh out the powder. It is important to strictly follow the monograph instructions, reconstitute the material in a buffer solvent and handle the resultant solution volumetrically.

Toxicity The potential toxicity of certain reference substances is such that special precautions should be taken to avoid contact. Such substances should be manipulated in a glove box. If this is not possible, gloves, eye protection and a mask should be worn. Following the guidelines suggested by the EP does not replace the need to carry out a full hazard assessment. Biological and blood products should be regarded as potentially hazardous to health and therefore used and disposed of according to established laboratory safety procedures.

Controlled Substances The EP’s product range contains substances subject to Controlled Substance regulations schedules. Special ordering procedures apply, so please contact LGC Standards for details and costs.

250

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia Code

Product

Unit

EPY0000055

Acamprosate calcium - Reference Spectrum

unit

EPY0000116

Acamprosate impurity A 3-aminopropane-1-sulphonic acid

EPY0000500

Acarbose

EPY0000354

Acarbose for identification

10 mg

EPY0000427

Acarbose for peak identification

40 mg

EPA0040000

Acebutolol hydrochloride

50 mg

EPY0000359

Acebutolol impurity B N-[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl) amino]propoxy]phenyl]acetamide (diacetolol)

10 mg

EPY0000127

Acebutolol impurity C N-(3-acetyl-4-hydroxyphenyl)butanamide

20 mg

EPY0000128

Acebutolol impurity I N-[3-acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]phenyl)butanamide

EPY0000056

Aceclofenac - Reference Spectrum

EPY0001094

Aceclofenac for peak identification

10 mg

EPY0000085

Aceclofenac impurity F benzyl[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate

20 mg

EPY0000086

Aceclofenac impurity H [[[[[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetyl]oxy]acetyl]oxy]acetic acid

10 mg

EPY0000810

Acemetacin

EPY0000811

Acemetacin impurity A 4-chlorobenzoic acid

EPY0000842

Acemetacine impurity mixture

EPA0070000

Acesulfame potassium

50 mg

EPA0070020

Acesulfame potassium impurity B 5-chloro-6-methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide

50 mg

EPA0100000

Acetazolamide

EPY0001084

Acetazolamide for system suitability

EPY0000002

Acetylcholine chloride

50 mg

EPA0150000

Acetylcysteine

50 mg

EPA0152000

Acetylcysteine impurity C N,N'-diacetyl-L-cystine

10 mg

EPA0153000

Acetylcysteine impurity D N,S-diacetyl-L-cysteine

10 mg

EPY0000565

ß-Acetyldigoxin

50 mg

EPY0000642

β-Acetyldigoxin for peak identification

10 mg

EPA0200000

Acetylsalicylic acid

15 mg

New EPY0001462

Acetylsulfadiazine

0.002 mg

50 mg 94.7 mg

0.004 mg unit

100 mg 10 mg 0.06 mg

100 mg 0.0068 mg

EPA0208000

N-Acetyltryptophan

125 mg

EPA0202000

N-Acetyltyrosine

200 mg

EPY0000693

Acholeplasma laidlawii BRP

EPA0220000

Aciclovir

75 mg

EPY0001264

Aciclovir for system suitability

10 mg

EPY0001271

Aciclovir for peak identification 1

0.3 mg

EPY0001269

Aciclovir for peak identification 2

0.004 mg

New EPY0001463

Actaea racemosa HRS

1200 mg

New EPY0001543

Actaea racemosa for assay CRS

300 mg

Acitretin

100 mg

EPA0225000 New EPY0001464

Actaea rasemosa dry extract for system suitability HRS

EPY0001121

Adapalene

EPY0001120

Adapalene impurity C 1-[2-(methyloxy)phenyl]tricyclo[3.3.1.1]decane

EPY0001119

Adapalene for peak identification

EPA0230000

Adenine

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

1 mL

1200 mg 100 mg 6 mg 2.022 mg 50 mg

251

European Pharmacopoeia Code

Product

EPA0230200

Adenosine

50 mg

EPY0000110

Adipic acid

50 mg

EPY0000882

Adrenaline

5 mg

EPY0000883

Adrenaline with impurity F

EPA0300000

Adrenaline tartrate

EPY0000740

Adrenaline impurity mixture

EPY0000707

Adrenaline tartrate with impurity A

EPY0000728

Agnus castus fruit standardised dry extract

EPA0325000

Alanine

60 mg

EPA0325100

Albendazole

50 mg

EPA0325200

Alcuronium chloride

50 mg

EPA0325450

Alfacalcidol

EPA0325451

Alfacalcidol - Reference Spectrum

EPA1225000

Alfadex

EPA0325500

Alfentanil hydrochloride - Reference Spectrum

EPA0325800

Alfuzosin hydrochloride

10 mg

EPY0000832

Alfuzosin for system suitability

10 mg

EPA0349000

Allantoin

EPA0350000

Allopurinol

EPA0350010

Allopurinol impurity A 5-amino-1H-pyrazole-4-carboxamide

10 mg

EPA0350020

Allopurinol impurity B 5-formylamino-1H-pyrazole-4-carboxamide

10 mg

EPA0350030

Allopurinol impurity C 5-(4H-1,2,4-triazol-4-yl)1H-pyrazole-4-carboxamide

10 mg

EPA0350040

Allopurinol impurity D ethyl 5-amino-1H-pyrazole-4-carboxylate

10 mg

EPA0350050

Allopurinol impurity E ethyl 5-(formylamino)-1H-pyrazole-4-carboxylate

20 mg

EPA0351000

Allylstrychnine bromide

10 mg

EPY0000235

Almagate

25 mg

EPY0000255

Almagate - Reference Spectrum

EPA0357000

Alprazolam Controlled Substance

100 mg

EPA0360000

Alprenolol hydrochloride

100 mg

EPY0000054

Alprostadil

EPY0000606

Altizide

EPY0000843

Altizide impurity B 3-[(2,2-dimethoxyethyl)sulphanyl]prop-1-ene

EPY0000687

Alverine citrate

EPY0000595

Alverine for peak identification

EPY0000607

Alverine impurity D N-(3-cyclohexylpropyl)-N-ethyl-3-phenylpropan-1-amine

EPA0363000

Amantadine hydrochloride

100 mg

EPA0363700

Ambroxol hydrochloride

125 mg

EPA0900000

Amfetamine sulfate - Reference Spectrum

EPA0365000

Amidotrizoic acid dihydrate

100 mg

EPA0368000

Amikacin

200 mg

New EPY0001467

Amikacin impurity I (2S)-4-amino-2-hydroxybutanoic acid

EPA0365900

Amikacin sulfate

EPY0001117

Amikacin for system suitability

EPA0370000

Amiloride hydrochloride

EPY0000020

Amiloride impurity A methyl-3,5-diamino-6-chloropyrazine-2-carboxylate

252

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Unit

10 mg 100 mg 0.005 mg 15 mg 200 mg

5 mg unit 150 mg unit

60 mg 100 mg

unit

50 mg 150 mg 15 mg 5 mg 0.125 mg 10 mg

unit

20 mg 200 mg 10 mg 100 mg 10 mg

Edition 2012/2013

European Pharmacopoeia Code

Product

EPY0000173

4-Aminobenzoic acid

Unit

60 mg

EPA0420000

Aminocaproic acid

50 mg

EPA0460000

7-Aminodesacetoxycephalosporanic acid

20 mg

EPA0496000

Aminoglutethimide

EPA0496005

Aminoglutethimide impurity A (3RS)-3-(3-aminophenyl)-3-ethylpiperidine-2,6-dione; (3-aminoglutethimide)

20 mg

EPA0496020

Aminoglutethimide impurity D 3,3'-[diazenediyldi(4,1-phenylene)]bis(3-ethylpiperidine-2,6-dione) (azoglutethimide)

10 mg

EPA0575000

Amiodarone hydrochloride

EPY0000129

Amiodarone impurity D (2-butyl-benzofuran-3-yl)-(4-hydroxy-3,5-diiodophenyl)methanone

20 mg

EPY0000130

Amiodarone impurity E (2-butylbenzofuran-3-yl)(4-hydroxyphenyl)methanone

20 mg

EPA0590000

Amisulpride

10 mg

EPA0590004

Amisulpride impurity B 4-amino-N-[[(2RS )-1-ethylpyrrolidin-2-yl] methyl]-5-(ethyl sulphonyl)-2-hydroxybenzamide

10 mg

EPY0000563

Amitriptyline hydrochloride

EPY0000049

Amlodipine besilate

EPY0001067

Amlodipine for peak identification

10 mg

EPY0001068

Amlodipine impurity A 3-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-2-[[2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2yl)ethoxy]methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate

10 mg

EPY0001069

Amlodipine impurity B 3-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-6-methyl-2-[[2-[[2(methylcarbamoyl)benzoyl]amino]ethoxy]methyl]-1,4-dihydropyridine-3,5-dicarboxylate

10 mg

EPY0001070

Amlodipine impurity G dimethyl 4-(2-chlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate

10 mg

EPY0000302

Ammonio methacrylate copolymer (type A) - Reference Spectrum

EPY0000303

Ammonio methacrylate copolymer (type B) - Reference Spectrum

EPA0650000

Amobarbital Controlled Substance

500 mg

EPA0700000

Amobarbital sodium Controlled Substance

500 mg

EPA0800000

Amoxicillin trihydrate

100 mg

EPY0000005

Amphotericin B

100 mg

EPY0001361

Amphotericin B for microbiological assay

100 mg

EPY0001014

Amphotericin B for peak identification

EPA1000000

Ampicillin (anhydrous)

250 mg

EPA1100000

Ampicillin trihydrate

150 mg

EPY0001244

Amylmetacresol

285 mg

EPY0001245

Amylmetacresol for peak identification

EPY0001386

Angelica dahuria root

EPA1200000

Anhydrotetracycline hydrochloride

15 mg

EPA1210000

Antazoline hydrochloride

50 mg

EPY0000172

Apomorphine hydrochloride - Reference Spectrum

EPY0001465

Apomorphine hydrochloride hemihydrate

15 mg

Apomorphine impurity B (Morphine sulfate) (Morphinhemisulfat-Pentahemihydrat) Controlled Substance

40 mg

New EPY0001471

125 mg

100 mg

10 mg 150 mg

unit unit

10 mg

10 mg 160 mg

unit

EPA1220000

Alpha-apo-oxytetracycline

20 mg

EPA1230000

Beta-apo-oxytetracycline

20 mg

EPA1250000

Aprotinin solution BRP

0.5 mL

EPY0001154

Aprotinin for system suitability

2.7 mg

EPA1269000

L-Arabinitol

10 mg

EPY0000806

Arbutin

100 mg

EPA1270000

Arginine

50 mg

EPY0000304

Arginine aspartate

20 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

253

European Pharmacopoeia Code

Product

EPA1271000

Arginine hydrochloride

New EPY0001323

Aristolochia

Unit

50 mg 140 mg

EPY0001185

Aristolochic acid I

1 mg

EPY0001175

Aristolochic acid for system suitability

EPY0000079

Articaine hydrochloride

EPY0000080

Articaine impurity A methyl3-[[2-(propylamino)acetyl]amino]-4-methylthiophene-2-carboxylate

15 mg

EPY0000081

Articaine impurity E methyl 4-methyl-3-[[(2RS)-2-[(1-methylethyl)amino]propanoyl] amino]thiophene-2-carboxylate

10 mg

EPA1300000

Ascorbic acid (Vitamin C)

100 mg

EPY0001024

Ascorbic acid impurity C D-sorbosonic acid

20 mg

EPY0001170

Ascorbic acid impurity D methyl D-xylo-hex-2-ulosonate (methyl D-sorbosonate)

10 mg

EPY0000800

Ascorbyl palmitate

10 mg

EPY0000305

Asparagine monohydrate

60 mg

EPA1320000

Aspartame

40 mg

EPA1321000

Aspartame impurity A 2-(5-benzyl-3,6-dioxopiperazin-2-yl)acetic acid (diketopiperazine)

10 mg

EPA1330000

Aspartic acid

50 mg

EPY0001171

Astragaloside IV

40 mg

EPA1340000

Atenolol

EPY0001089

Atenolol for system suitability

EPY0001327

Atorvastatine calcium trihydrate

EPY0001328

Atorvastatin impurity A desfluoroatorvastatin

10 mg

EPY0001329

Atorvastatin impurity B 3-epi-atorvastatin

10 mg

EPY0001330

Atorvastatin impurity C fluoroatorvastatin

10 mg

EPY0001331

Atorvastatin impurity D 3-[(4-fluorophenyl)carbonyl]-2-(2-methylpropanoyl)-N,3-diphenyloxirane-2-carboxamide

10 mg

EPY0001332

Atorvastatin impurity E ent-atorvastatin

10 mg

EPY0000424

Atracurium besilate

EPY0000503

Atracurium for impurity F identification

5 mg

EPY0000504

Atracurium for peak identification

5 mg

EPY0000878

Atropine

EPY0000845

Atropine for peak identification

EPY0000816

Atropine impurity B (1R,3r,5S)-8-azabicyclo[3.2.1]oct-3-yl (2RS)-3-hydroxy-2-phenylpropanoate (noratropine)

10 mg

EPA1400000

Atropine sulphate

50 mg

EPY0000029

Azaperone

50 mg

EPA1500000

Azathioprine

EPY0001240

Azathioprine impurity A 1-methyl-4-nitro-1H-imidazol-5-amine

EPY0001246

Azathioprine impurity G 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)sulfanyl]-7H-purin-2-amine (thiamiprine)

EPY0000326

Azelastine hydrochloride

EPY0000327

Azelastine impurity B 1-benzoyl-2-[(4RS)-1-methylhexahydro-1H-azepin-4-yl]diazane

5 mg

EPY0000328

Azelastine impurity D 4-(4-chlorobenzyl)phthalazin-1(2H)-one

5 mg

EPY0000329

Azelastine impurity E 3-(4-chlorobenzilidene)isobenzofuran-1(3H)-one

5 mg

254

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

1 mg 100 mg

100 mg 5 mg 150 mg

120 mg

30 mg 0.25 mg

100 mg 10 mg 5 mg 25 mg

Edition 2012/2013

European Pharmacopoeia Code

Product

EPY0000306

Azithromycin

Unit

EPY0000637

Azithromycin for peak identification

EPY0000641

Azithromycin for system suitability

EPY0000307

Azithromycin impurity A 6-demethylazithromycin

EPY0000285

B19 virus DNA for NAT testing BRP

150 mg

EPB0070000

Bacampicillin hydrochloride

120 mg

EPB0100000

Bacitracin zinc

150 mg

EPB0200000

Baclofen

50 mg

EPB0200050

Baclofen impurity A (RS)-4-amino-3-(4-chlorophenyl)butyric acid lactam

50 mg

EPY0001273

Baicalin

10 mg

EPB0250000

Bambuterol hydrochloride

100 mg

EPB0300000

Barbital Controlled Substance

500 mg

EPY0000295

Basic butylated methacrylate copolymer - Reference Spectrum

EPB0305000

Beclometasone dipropionate anhydrous

EPY0000351

Beclometasone dipropionate monohydrate

10 mg

EPY0000352

Beclometasone dipropionate for system suitability

10 mg

EPY0000469

Beclometasone dipropionate for peak identification

10 mg

EPY0001073

Beclometasone dipropionate impurities F and N

EPY0001025

Benazepril hydrochloride

EPY0001038

Benazepril for system suitability

EPY0001026

Benazepril impurity A [(3R)-3-[[(1R)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2-oxo-2,3,4,5-tetrahydro-1H-1benzazepin-1-yl]acetic acid

EPB0400000

Bendroflumethiazide

EPY0000564

Bendroflumethiazide impurity A 4-amino-6-(trifluoromethyl)benzene-1,3-disulphonamide

EPY0000044

Benfluorex hydrochloride

EPY0000043

Benfluorex hydrochloride for system suitability

360 mg

EPB0470000

Benperidol

100 mg

EPB0477000

Benserazide hydrochloride

50 mg

EPB0477010

Benserazide impurity A (RS)-2-amino-3-hydroxypropanohydrazide

20 mg

EPY0001071

Benserazide impurity C (2RS)-2-amino-3-hydroxy-2'-[(1EZ)-(2,3,4-trihydroxybenzylidene)]propanohydrazide

10 mg

EPY0001079

Benserazide for peak identification

10 mg

200 mg 15 mg 0.05 mg 10 mg

unit 150 mg

0.052 mg 160 mg 0.016 mg 10 mg

100 mg 5 mg 50 mg

EPY0001064

Benzaldehyde

EPY0001060

Benzalkonium chloride for system suitability

150 mg 20 mg

EPB0490000

Benzarone (2-ethylbenzofuran-3-yl)(4-hydroxyphenyl)methanone

10 mg

EPB0500000

Benzathine benzylpenicillin

125 mg

EPY0000775

Benzbromarone

EPB0550000

Benzethonium chloride

EPB0600000

Benzocaine

50 mg

Benzoic acid

30 mg

EPY0000647

Benzophenone

40 mg

EPY0000167

Benzyl alcohol

50 mg

EPB0670000

Benzyl benzoate - Reference Spectrum

EPB0680000

S-Benzylmercaptoacetyltriglycin

10 mg

EPB0700000

Benzylpenicillin potassium

50 mg

New EPY0001470

EPB0900000

Benzylpenicillin sodium

EPY0001149

Berberine chloride

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

10 mg 100 mg

unit

200 mg 20 mg

255

European Pharmacopoeia Code

Product

EPB0950000

Betadex

EPY0000391

Betahistine dihydrochloride

EPB0990000

Betahistine mesilate

Unit

200 mg 50 mg 100 mg

EPB1000000

Betamethasone

EPB1030000

Betamethasone acetate

100 mg

75 mg

EPB1040000

Betamethasone diproprionate

150 mg

New EPY0001416

Betamethasone dipropionate for peak identification

10 mg

New EPY0001418

Betamethasone dipropionate for system suitability

10 mg

EPB1045000

Betamethasone sodium phosphate

100 mg

EPB1054000

Betamethasone-17-valerate

100 mg

EPB1055000

Betamethasone-21-valerate

15 mg

EPY0001027

Betamethasone valerate for system suitability

25 mg

EPY0001065

Betamethasone valerate impurity mixture

EPY0001360

Betaxolol for peak identification

15 mg

EPB1103000

Betaxolol hydrochloride

60 mg

EPB1103100

Betaxolol impurity A (2RS)-1-(4-ethylphenoxy)-3-[(1-methylethyl)-amino]propan-2-ol

10 mg

EPY0001354

Betaxolol impurity C 2-[[4-[2-(cyclopropylmethoxy)ethyl]phenoxy]methyl]oxirane

EPB1115000

0.018 mg

5 mg

Bezafibrate

100 mg

New EPY0001444

Bicalutamide

100 mg

New EPY0001448

Bicalutamide for system suitability

15 mg

Bicisate labelling kit

24 mg

EPY0001078 EPB1110000 New EPY0001421

Bifonazole

100 mg

EPB1110004

Bifonazole for system suitability Bifonazole impurity B 4-[(RS)-(biphenyl-4-yl)phenylmethyl]-1H-imidazole trifluoroacetate

10 mg

EPY0001059

Bilberry dry extract

250 mg

EPB1116000

Biotin (Vitamin H)

20 mg

EPB1120000

Biperiden hydrochloride

60 mg

EPB1121000

Biperiden impurity A (1RS)-1-[(1SR,2SR,4SR)-bicyclo[2.2.1]hept-5-en-2-yl]-1-phenyl-3-(piperidin-1-yl)propan-1-ol (endo form)

20 mg

EPB1140000

Bisacodyl

50 mg

EPY0000608

Bisacodyl for peak identification

10 mg

EPY0000694

Bisacodyl for system suitability

5 mg

EPY0000812

Bisoprolol fumarate

EPY0000877

Bisoprolol for peak identification Bisoprolol for system suitability method A CRS has been renamed as Bisoprolol for peak identification CRS

1 mg

EPY0000813

Bisoprolol for system suitability Bisoprolol for system suitability method B CRS has been renamed as Bisoprolol for system suitability CRS

1 mg

EPB1141000

Bleomycin sulfate

7 mg

10 mg

50 mg

EPY0000434

Boldine

30 mg

EPB1142000

Bordetella pertussis mouse antiserum BRP

0.5 mg

EPB1143000

Bromazepam Controlled Substance

60 mg

EPY0000645

Bromazepam for system suitability Controlled Substance

EPB1145000

Bromhexine hydrochloride

10 mg

EPY0000200

Bromhexine impurity C N-(2-aminobenzyl)-N-methylcyclohexanamine

10 mg

EPB1150000

Bromocriptine mesilate

30 mg

EPY0000677

Bromocriptine mesilate for system suitability

EPB1152000

Bromperidol

256

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg

5 mg 100 mg

Edition 2012/2013

European Pharmacopoeia Code

Product

EPB1152050

Bromperidol decanoate

Unit

EPB1153000

Brompheniramine maleate

EPY0000468

Brotizolam Controlled Substance

10 mg

EPY0000470

Brotizolam impurity B 2-bromo-4-(2-chlorophenyl)-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine (demethylbrotizolam)

10 mg

EPB1155000

Brucella melitensis Rev. 1 strain BRP

60 mg 100 mg

1 mL

EPB1157300

Budesonide

EPY0001148

Budesonide for system suitability

110 mg

EPB1156000

Bufexamac

100 mg

EPB1157400

Buflomedil hydrochloride

100 mg

EPB1157410

Buflomedil impurity B 4-(pyrrolidin-1-yl)-1-(4-hydroxy-2,6-dimethoxyphenyl)butan-1-one

EPB1158000

Bumetanide

EPY0000309

Bumetanide impurity A 3-nitro-4-phenoxy-5-sulphamoylbenzoic acid

5 mg

EPY0000310

Bumetanide impurity B 3-amino-4-phenoxy-5-sulphamoylbenzoic acid

5 mg

EPB1160000

Bupivacaine hydrochloride

EPY0000088

Bupivacaine impurity B (2RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide

20 mg

EPY0000089

Bupivacaine impurity E 6-(butylamino)-N-(2,6-dimethylphenyl)hexanamide

20 mg

EPY0001108

Buprenorphine Controlled Substance

10 mg

EPY0001109

Buprenorphine hydrochloride Controlled Substance

10 mg

EPY0001122

Buprenorphine for system suitability Controlled Substance

10 mg

EPB1168000

Buserelin

EPB1168020

D-His-Buserelin

10 mg

20 mg 150 mg

100 mg

2 mg 0.5 mg

EPY0000131

Buspirone hydrochloride

5 mg

EPY0000471

Buspirone for system suitability

2 mg

EPB1170000

Busulfan

EPY0001304

Butyl methanesulfonate

EPB1217000

Butyl parahydroxybenzoate

EPY0001357

Butyl parahydroxybenzoate impurity E 2-methylpropyl 4-hydroxybenzoate (iso-butyl parahydroxybenzoate)

50 mg 30 µl 100 mg 15 mg

EPB1212000

Butylhydroxyanisole

50 mg

EPB1215000

Butylhydroxytoluene Plastic additive 07

50 mg

EPY0000472

Cabergoline

100 mg

EPC0100000

Caffeine

70 mg

EPY0000787

Caffeine for system suitability

20 mg

EPC0166000

Calcifediol

EPC0166001

Calcifediol - Reference Spectrum

5 mg unit

EPY0000499

Calcipotriol (anhydrous) - Reference Spectrum

unit

EPY0000473

Calcipotriol monohydrate

EPY0000474

Calcipotriol monohydrate - Reference Spectrum

5 mg

EPC0200000

Calcitonin (salmon)

EPY0000632

Calcitonin-Gly

0.4 mL

EPC0200010

N-acetyl-cys1-calcitonin

20 mg

EPC0225000

Calcitriol

10 mg

EPC0226000

Calcitriol - Reference Spectrum

EPC0249000

Calcium ascorbate - Reference Spectrum

EPC0250000

Calcium folinate

EPC0299000

Calcium glucoheptonate

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

unit 2x0.98 mg

unit unit 100 mg 60 mg 257

European Pharmacopoeia Code

Product

EPC0300000

Calcium gluconate

Unit

100 mg

EPC0340000

Calcium levulinate dihydrate

250 mg

EPC0350000

Calcium oxalate monohydrate

500 mg

EPC0400000

Calcium pantothenate

60 mg

EPC0405000

Camphor (racemic)

50 mg

EPY0001388

Candesartan cilexetil

60 mg

New EPY0001387

Candesartan cilexetil for peak identification

10 mg

EPY0001389

Candesartan cilexetil for system suitability

10 mg

EPC0410000

Canrenone

EPC0426000

Caprylic acid

50 mg 200 mg

EPY0000671

Capsaicin

50 mg

EPC0430000

Captopril

10 mg

EPY0001182

Captopril for system suitability Captopril impurity B (2S) 1-[(2S)-3-bromo-2-methylpropanoyl]pyrrolidine-2-carboxylic acid

20 mg

EPY0001220

Captopril impurity C (2RS)-2-methyl-3-sulphanylpropanoic acid

10 mg

EPY0001221

Captopril impurity D (2RS)-3-bromo-2-methylpropanoic acid

10 mg

EPY0000435

Captopril impurity E (2S)-1-isobutyryl-pyrrolidine-2-carboxylic acid

10 mg

Captopril impurity J (2S)-1-[(2S)-3-(acetylsulfanyl)-2-methylpropanoyl]pyrrolidine-2-carboxylic acid (acetylcaptopril)

10 mg

EPY0001219

New EPY0001450

EPY0000113

Carbachol

EPC0450000

Carbamazepine

EPY0000033

Carbamazepine impurity A 10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide(10,11-dihydrocarbamazepine)

EPC0451000

Carbasalate calcium - Reference Spectrum

EPY0001161

Carbasalate impurity B 2-[[2-(acetyloxy)benzoyl]oxy]benzoic acid (acetylsalicylsalicylic acid)

10 mg

50 mg 200 mg 10 mg unit 5 mg

EPC0455000

Carbenicillin sodium

50 mg

EPC0460000

Carbidopa

50 mg

EPC0465000

Carbimazole

100 mg

EPC0470000

Carbocisteine

60 mg

EPC0499900

Carbon dioxide - Reference Spectrum

unit

EPC0550000

Carboplatin - Reference Spectrum

unit

EPY0000475

Carboprost trometamol

EPY0000536

Carboprost trometamol - Reference Spectrum

EPY0000035

Carisoprodol

50 mg

EPY0000036

Carisoprodol impurity A (2RS)-2-(hydroxymethyl)-2-methylpentyl(1-methylethyl)carbamate

10 mg

EPY0001214

Carmellose

10 mg

EPC0580004

Carmustine - Reference Spectrum

EPC0580010

Carmustine impurity A 1,3-bis(2-chloroethyl)urea

20 mg

EPY0000846

Carprofen for veterinary use

30 mg

EPY0000884

Carprofen for system suitability

EPY0000192

Carteolol hydrochloride - Reference Spectrum

EPY0000193

Carteolol for system suitability

EPY0000075

Carvedilol - Reference Spectrum

40 mg unit

unit

5 mg unit 30 mg unit

New EPY0001427

Carvedilol

50 mg

New EPY0001426

Carvedilol for system suitability

10 mg

EPY0000103

Carvedilol impurity C (2RS)-1-[benzyl[2-(2-methoxyphenoxy)ethyl]amino]-3-(9H-carbazol-4-yloxy) propan-2-ol

10 mg

258

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia Code

Product

EPC0600000

Casein BRP

EPC0630000

Cefaclor

EPC0640000

Delta-3-Cefaclor

Unit

100 g 450 mg 20 mg

EPC0650000

Cefadroxil

250 mg

EPC0675000

Cefalexin monohydrate

150 mg

EPC0682000

Cefalotin sodium

100 mg

EPY0000505

Cefalotin for impurity B identification

EPC0682300

Cefamandole nafate

125 mg

10 mg

EPY0000240

Cefapirin sodium

100 mg

EPC0682400

Cefatrizine propylene glycol

150 mg

EPC0682410

Cefatrizine impurity A 7-amino-(6R,7R)-3-[(2H-1,2,3-triazol-4-yl)sulfanyl]-methyl-8-oxo-5-thia-1azabicyclo[4.2.O]oct-2-ene-2-carboxylic acid(7-ACA triazole)

EPC0682800

Cefazolin

150 mg

EPY0000633

Cefepime dihydrochloride monohydrate

150 mg

EPY0000634

Cefepime dihydrochloride monohydrate for system suitability

15 mg

EPY0001336

Cefepime impurity E (6R,7R)-7-amino-3-[(1-methylpyrrolidinio)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct2-ene-2-carboxylate

10 mg

EPC0684000

Cefixime

200 mg

EPC0684750

Cefoperazone dihydrate

100 mg

EPC0684800

Cefoperazone sodium - Reference Spectrum

EPY0000420

Cefotaxime acid

EPC0685000

Cefotaxime sodium

30 mg

EPY0000506

Cefotaxime for peak identification

10 mg

EPC0688000

Cefoxitin sodium

EPY0001305

Cefpodoxime proxetil

70 mg

EPY0001306

Cefpodoxime proxetil for peak identification

10 mg

EPY0001318

Cefpodoxime proxetil for impurity H identification

10 mg

60 mg

unit 80 mg

100 mg

New EPY0001371

Cefprozil

New EPY0001372

Cefprozil impurity A (2R)-2-amino-2-(4-hydroxyphenyl)acetic acid (p-hydroxyphenylglycine)

20 mg

New EPY0001367

Cefprozil for peak identification

10 mg

New EPY0001368

Cefprozil impurity mixture

10 mg

EPC0690000

Cefradine

EPY0000568

Cefradine for peak identification

120 mg

300 mg 15 mg

EPY0001174

Cefradine impurity mixture

0.04 mg

EPC0690500

Ceftazidime

200 mg

EPY0001111

Ceftazidime for peak identification

10 mg

EPC0691000

Ceftriaxone sodium

80 mg

EPC0692000

Ceftriaxone impurity A E-isomer

10 mg

EPC0694990

Cefuroxime axetil

60 mg

EPC0695000

Cefuroxime sodium

150 mg

New EPY0001445

Celecoxib

200 mg

New EPY0001446

Celecoxib impurity A 4-[5-(3-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide

10 mg

New EPY0001447

Celecoxib impurity B 4-[3-(4-methylphenyl)-5-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide

10 mg

EPY0000311

Celiprolol hydrochloirde

EPY0000312

Celiprolol impurity I 1-acetyl-1-(4-ethoxyphenyl)-3,3-diethylurea

10 mg

EPY0000239

Celiprolol for peak identification

20 mg

EPY0000784

Cellulose acetate

40 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

0.02 mg

259

European Pharmacopoeia Code

Product

Unit

EPC0698005

Cellulose acetate butyrate - Reference Spectrum

unit

EPY0001054

Cellulose acetate phthalate

10 mg

EPC0700000

Cephaeline hydrochloride

15 mg

EPC0980650

Cetirizine dihydrochloride

100 mg

EPY0001197

Cetirizine for peak identification

1.01 mg

EPC0980651

Cetirizine impurity A (RS)-1-[(4-chlorophenyl)phenylmethyl]piperazine

EPC0984100

Cetostearyl isononanoate - Reference Spectrum

EPC0990000

Cetyl alcohol

EPY0000073

Cetyl palmitate 15

60 mg

EPY0000074

Cetyl palmitate 95

50 mg

EPC1000000

Cetylpyridinium chloride

20 mg

EPC1050000

Chenodeoxycholic acid

125 mg

EPY0000104

Chitosan hydrochloride

30 mg

10 mg unit 250 mg

EPC1100000

Chlorambucil

EPY0001298

Chlorambucil for system suitability

100 mg 10 mg

EPY0001299

Chlorambucil with impurity G

10 mg

EPC1200000

Chloramphenicol

500 mg

EPC1300000

Chloramphenicol dipalmitate

100 mg

EPC1350000

Chloramphenicol disodium disuccinate

EPC1400000

Chloramphenicol palmitate isomer

100 mg

25 mg

EPC1425000

Chloramphenicol sodium succinate

1500 mg

EPC1435000

Chlorcyclizine hydrochloride

EPC1450000

Chlordiazepoxide Controlled Substance

100 mg 2x50 mg

EPC1500000

Chlordiazepoxide hydrochloride Controlled Substance

EPY0000476

Chlordiazepoxide impurity A 7-chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one 4-oxide

10 mg

EPC1510000

Chlorhexidine

50 mg

EPC1520000

Chlorhexidine diacetate

10 mg

EPC1540000

Chlorhexidine dihydrochloride

50 mg

EPC1530000

Chlorhexidine for performance test

50 mg

EPY0000569

Chlorogenic acid

20 mg

EPC2223030

1-(4-Chlorophenyl)-1-phenylethanol Clemastine fumarate impurity C

15 mg

EPC1650000

Chloroquine sulphate

200 mg

EPC1700000

Chlorothiazide

100 mg

EPC1800000

Chlorphenamine maleate

100 mg

EPY0000436

Chlorphenamine impurity A 2-(4-chlorophenyl)-4-(dimethylamino)-2-[2-(dimethylamino)ethyl]butanenitrile

0.01 mg

EPY0000437

Chlorphenamine impurity C (3RS)-3-(4-chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine

EPC1900000

Chlorpromazine hydrochloride

EPY0000507

Chlorpromazine impurity A 3-(2-chloro-10H-phenothiazin-10-yl)-N,N-dimethylpropan-1- amine S-oxide (chlorpromazine sulphoxide)

10 mg

EPY0000479

Chlorpromazine impurity D 3-(2-chloro-10H-phenothiazin-10-yl)-N-methypropan-1-amine (demethylchlorpromazine)

10 mg

Chlorpromazine impurity E 2-chloro-10H-phenothiazine

10 mg

New EPY0000508 EPY0001449

Chlorpromazine impurity F 3-(4-chloro-10H-phenothiazin-10-yl)-N,N-dimethylpropan-1-amine

EPC1905000

Chlorpropamide

EPC1905020

Chlorpropamide impurity B 1,3-Dipropylurea

260

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg

10 mg 200 mg

2 mg 100 mg 50 mg

Edition 2012/2013

European Pharmacopoeia Code

Product

EPC1915000

Chlorprothixene hydrochloride

EPC1950000

Chlortalidone

EPY0000779

Chlortalidone for peak identification

EPC2000000

Chlortetracycline hydrochloride

EPY0001451

Chlortetracycline for system suitability

EPC2100000

Cholecalciferol

EPC2150000

Cholecalciferol for system suitability

EPC2155000

Cholesterol

Unit

50 mg 150 mg 1.017 mg 100 mg 20 mg 500 mg 1 mL 100 mg

EPC2158000

Cholic acid

EPY0000280

Chondroitin sulfate sodium

250 mg

EPY0000593

Chondroitin sulfate sodium (marine)

100 mg

EPC2160000

Chymotrypsin BRP

100 mg

EPY0000040

Ciclopirox

100 mg

EPC2162701

Ciclopirox impurity A (RS)-2-(3-cyclohexyl-5-methyl-4,5-dihydroisoxazol-5-yl)acetic acid

20 mg

EPC2162702

Ciclopirox impurity B 6-cyclohexyl-4-methyl-2H-pyran-2-one

20 mg

EPC2162700

Ciclopirox olamine

150 mg

EPC2163000

Ciclosporin

120 mg

EPY0000361

Ciclosporin for system suitability

EPC2170000

Cilastatin sodium

10 mg

EPC2174000

Cilazapril

50 mg

EPC2174002

Cilazapril impurity A 1,1-dimethylethyl(1S,9S)-9-[[(S)-1-ethoxycarbonyl-3-phenylpropyl]amino]10-oxo-octahydro-6H-pyridazino[1,2a][1,2]diazepine-1-caboxylate

25 mg

EPC2174005

Cilazapril impurity D (1S,9S)-9-[[(R)-1-ethoxycarbonyl-3-phenylpropyl]amino]-10-oxo-octahydro-6Hpyridazino[1,2a][1,2]diazepine-1-carboxylic acid

10 mg

EPC2175000

Cimetidine

50 mg

EPC2175500

Cimetidine hydrochloride

EPY0001130

Cimetidine for peak identification

EPY0001146

Cimetidine for system suitability

EPC2177000

Cinchocaine hydrochloride

60 mg

5 mg

100 mg 10 mg 0.5085 mg 60 mg

EPY0000176

Cineole

180 mg

EPC2180000

Cinnarizine

100 mg

EPY0000362

Ciprofibrate

5 mg

EPY0000363

Ciprofibrate for system suitability

EPY0000198

Ciprofloxacin

5 mg 20 mg

EPC2190000

Ciprofloxacin hydrochloride

EPY0000199

Ciprofloxacin hydrochloride for peak identification

100 mg 10 mg

EPC2190050

Ciprofloxacin impurity A 7-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-quinoline-3-carboxylic acid (fluoroquinolonic acid)

10 mg

EPC2210000

Cisplatin

EPY0001018

Cisplatin impurity A trans-diamminedichloroplatinium (II)

10 mg

EPY0001019

Cisplatin impurity B amminetrichloroplatinate (-)

10 mg

EPY0001008

Citalopram hydrobromide

5 mg

EPY0001007

Citalopram hydrochloride

5 mg

EPY0000855

Citalopram for system suitability

100 mg

0.06 mg

EPA1202000

Citric acid (anhydrous)

50 mg

EPC2219000

Citric acid monohydrate

50 mg

EPY0000639

Cladribine

50 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

261

European Pharmacopoeia Code

Product

EPY0000609

Cladribine for peak identification

EPY0000610

Cladribine impurity C 2-chloro-7H-purin-6-amine

Unit

10 mg 5 mg

EPY0000320

Clarithromycin

EPY0000321

Clarithromycin for peak identification

40 mg

Clazuril

10 mg

Clazuril for system suitability

10 mg

New EPY0001193 EPY0000269

160 mg

EPC2221000

Clebopride malate

100 mg

EPC2223000

Clemastine fumarate

100 mg

EPC2248000

Clenbuterol hydrochloride

30 mg

EPC2248010

Clenbuterol impurity B 1-(4-amino-3,5-dichlorophenyl)-2-[(1,1-dimethylethyl)amino]ethanone (clenbuterol ketone)

10 mg

EPC2250000

Clindamycin hydrochloride

200 mg

EPC2269000

Clindamycin phosphate

250 mg

EPY0000364

Clioquinol

EPY0000205

Clobazam - Reference Spectrum

5 mg

EPY0000241

Clobazam impurity A 7-chloro-5-phenyl-1,5-dihydro-1,5-dihydro-3H-1,5-benzodiazepine-2,4-dione

10 mg

EPY0000559

Clobetasol propionate

40 mg

EPY0000570

Clobetasol for peak identification

EPY0000571

Clobetasol impurity J (17R)-4'-chloro-5'-ethyl-9-fluoro-11ß-hydroxy-16ß-methylspiro[androsta-1,4-diene17,2'(3'H)-furan]-3,3'-dione (17 alpha-spiro compound)

0.4 mg

EPC2285000

Clobetasone butyrate

50 mg

EPY0001137

Clobetasone butyrate for system suitability

30 mg

EPY0000888

Clodronate disodium tetrahydrate

5 mg

EPY0000885

Clodronate impurity D (chloromethylene)bis(phosphonic acid)

5 mg

EPY0000313

Clofazimine

EPY0000358

Clofazimine for system suitability

10 mg

EPC2300000

Clofibrate

0.5 mL

unit

2 mg

150 mg

EPC2320000

Clomifene citrate

50 mg

EPC2332000

Clomifene citrate for performance test

50 mg

EPC2360000

Clomipramine hydrochloride

EPY0000132

Clomipramine impurity C 3-(3-chloro-5H-dibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-1-amine

10 mg

EPY0000133

Clomipramine impurity D 3-(3,7-dichloro-10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl) N,N-dimethylpropan-1-amine

10 mg

EPY0000134

Clomipramine impurity F 3-chloro-10,11-dihydro-5H-dibenzo[b,f]azepine

100 mg

5 mg

EPC2385000

Clonazepam Controlled Substance

EPY0000286

Clonazepam - Reference Spectrum

50 mg

EPC2385015

Clonazepam impurity B 3-Amino-4-(2-chlorophenyl)-6-nitro-1H-quinolin-2-one

EPC2400000

Clonidine hydrochloride

EPY0000801

Clonidine impurity B 1-acetyl-2-[(2,6-dichlorophenyl)amino]-4,5-dihydro-1H-imidazole

20 mg

EPY0000833

Clopamide

40 mg

EPY0000848

Clopamide for system suitability

10 mg

EPY0001333

Clopidogrel hydrogen sulfate

60 mg

EPY0001334

Clopidogrel for system suitability

EPY0001335

Clopidogrel impurity A (2S)-(2-chlorophenyl)[6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]acetic acid

10 mg

EPY0000392

Closantel sodium dihydrate

20 mg

262

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

unit 5 mg 100 mg

100 mg

Edition 2012/2013

European Pharmacopoeia Code

Product

EPY0000393

Closantel for system suitability

EPC2424400

Clostridia (multi-component) rabbit antiserum (for vaccines-vet.use) BRP

EPC2424550

Clostridium tetani guinea pig antiserum (for vaccines-human use) BRP

3x1 mg

EPC2424500

Clostridium tetani guinea pig antiserum (for vaccines - vet.use) BRP

1 mg

EPC2425600

Clostridium tetani rabbit antiserum (for vaccines - vet.use) BRP

1 mg

EPC2430000

Clotrimazole

EPY0000818

Clotrimazole impurity E (2-chlorophenyl)phenylmethanone (2-chlorobenzophenone)

EPY0000849

Clotrimazole for peak identification

EPC2450000

Cloxacillin sodium

EPC2460000

Clozapine

EPY0000758

Clozapine for peak identification

New EPY0001472

Coagulation Factors V, VIII, XI and XIII plasma

Unit

20 mg 1 mg

100 mg 15 mg 1 mg 200 mg 60 mg 0.41 mg 2x1 mg

EPY0000162

Cocaine hydrochloride - Reference Spectrum

EPC2480000

Cocoyl caprylocaprate

40 mg

EPY0000722

Codeine Controlled Substance

20 mg

EPC2500000

Codeine - Reference Spectrum

EPY0000334

Codeine impurity A 7,8-didehydro-4,5α-epoxy-3,6α-dimethoxy-17-methylmorphinan (o-methylcodeine) Controlled Substance

EPC2500100

Codeine hydrochloride dihydrate - Reference Spectrum

EPC2510000

Codergocrine mesilate

unit

unit 10 mg

unit 60 mg

EPC2580000

Colchicine

15 mg

EPY0000209

Colchicine for system suitability

10 mg

EPY0000374

Colestyramine

10 mg

EPC2600000

Colistimethate sodium

20 mg

EPY0000277

Colistin sulfate

25 mg

EPC2700000

Colistin sulfate for microbiological assay

25 mg

EPC2725000

Copovidone - Reference Spectrum

EPC2800000

Cortisone acetate

EPY0000438

Coumarin

EPC2900000

Cotton wool standard for neps

EPY0001053

Crospovidone

EPC2970000

Crotamiton

EPC2970005

Crotamiton impurity A N-ethyl-N-(2-methylphenyl)but-3-enamide

70 mg

EPY0001061

Cyanidin chloride

20 mg

EPC3000000

Cyanocobalamin

20 mg

EPC3090000

Cyclizine hydrochloride

50 mg

EPY0000886

Cyclizine impurity A 1-methylpiperazine

15 mg

EPY0000887

Cyclizine impurity B diphenylmethanol (benzhydrol)

10 mg

EPC3200000

Cyclobenzaprine hydrochloride

100 mg

EPC3245000

Cyclopentolate hydrochloride

EPY0001088

Cyclopentolate for system suitability

unit 250 mg 80 mg 1000 mg 5 mg 100 mg

2x50 mg 60 mg

EPC3250000

Cyclophosphamide

50 mg

EPC3280000

Cyproheptadine hydrochloride

30 mg

EPY0001095

Cyproheptadine impurity C 5-(1-methylpiperidin-4-yl)-5H-dibenzo[a,d][7]annulen-5-ol

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

5 mg

263

European Pharmacopoeia Code

Product

EPC3283000

Cyproterone acetate

Unit

EPY0001390

Cyproterone acetate for peak identification

EPY0001223

Cyproterone impurity mixture

EPC3290000

Cysteine hydrochloride monohydrate

EPC3300000

Cystine

100 mg

EPC3350000

Cytarabine

150 mg

30 mg 5 mg 0.01 mg 50 mg

EPY0000733

Dacarbazine

20 mg

EPY0000734

Dacarbazine impurity A 3,7-dihydro-4H-imidazo[4,5-d]-1,2,3-triazin-4-one (2-azahypoxanthine)

20 mg

EPY0000735

Dacarbazine impurity B 5-amino-1H-imidazole-carboxamide

10 mg

EPD0070000

Dalteparin sodium

250 mg

EPY0000600

Danaparoid sodium

EPD0100000

Dapsone

100 mg

10 mg

EPD0125000

Daunorubicin hydrochloride

100 mg

EPD0120000

Daunorubicinone Daunorubicin aglycone

10 mg

EPD0160000

Deferoxamine mesilate

30 mg

EPD0201000

Dehydrohexetidine 2-ethyl-N-[[1-(2-ethylhexyl)-4-methyl-4,5-dihydro-1H-imidazol-4-yl]methyl]hexan-1-amine

50 mg

EPY0000611

Dembrexine hydrochloride monohydrate

EPD0300000

Demeclocycline hydrochloride

EPD0350000

N-Demethylerythromycin A

EPY0000228

Demethylflumazenil - Reference Spectrum

EPD0406200

Deptropine citrate

10 mg 100 mg 10 mg unit 60 mg

EPD0430000

Dequalinium chloride

50 mg

EPD0431000

Dequalinium chloride for performance test

50 mg

EPY0001321

Dermatan sulfate and oversulfated chondroitin sulfate

EPD0480000

Desacetylvinblastine

EPY0000879

Desflurance - Reference Spectrum

EPY0000807

Desflurane impurity A 1,1'-oxybis(1,2,2,2-tetrafluoroethane)

EPD0500000

Desipramine hydrochloride

100 mg

EPD0600000

Deslanoside

150 mg

EPD0630000

Desmethylmetrifonate

EPD0650000

Desmopressin

1 mL 2x1 mg unit 1 mL

30 mg 0.98 mg

EPY0000509

Desogestrel

50 mg

EPY0000510

Desogestrel for system suitability

10 mg

EPD0400000

Desoxycortone acetate

100 mg

EPY0000001

Detomidine hydrochloride

100 mg

EPD0660020

Detomidine impurity B (RS)-(1-benzyl-1H-imidazol-5-yl)(2,3-dimethylphenyl)methanol

20 mg

EPD0700000

Dexamethasone

50 mg

EPY0001177

Dexamethasone for system suitability

10 mg

EPD0710000

Dexamethasone acetate

EPY0001169

Dexamethasone acetate impurity E 9-fluoro-11beta,17-dihydroxy-16alpha-methyl-3,20-dioxopregn-4-en-21-yl acetate

EPY0000538

Dexamethasone isonicotinate

10 mg

EPY0000511

Dexamethasone isonicotinate for impurity C identification

10 mg

EPD0718000

Dexamethasone pivalate

EPD0720000

Dexamethasone sodium phosphate

New EPY0001477

100 mg 0.013 mg

50 mg 100 mg

Dexamethasone sodium phosphate for peak identification

10 mg

EPD0720800

Dexchlorpheniramine maleate

60 mg

264

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia Code

Product

EPD0730000

Dexpanthenol

Unit

EPD0731000

Dextran

25 mg

EPD0731005

Dextran 1

50 mg

EPD0732000

Dextran Vo

10 mg

EPD0733000

Dextran 4 for calibration

50 mg

EPD0734000

Dextran 10 for calibration

50 mg

EPD0735000

Dextran 40 for calibration

50 mg

EPD0736000

Dextran 70 for calibration

50 mg

5 mg

EPD0737000

Dextran 250 for calibration

50 mg

EPD0738000

Dextran 40 for performance test

50 mg

EPD0739000

Dextran 60/70 for performance test

50 mg

EPY0000744

Dextranomer

50 mg

EPD0740000

Dextromethorphan hydrobromide

EPY0000261

Dextromethorphan impurity A ent-3-methoxymorphinan

EPY0001058

Dextropropoxyphene hydrochloride Controlled Substance

EPY0001150

Dextropropoxyphene for system suitability Controlled Substance

EPD0940000

Diazepam Controlled Substance

30 mg

EPY0000596

Diazepam for system suitability Controlled Substance

0.5 mg

EPD0950000

Diazoxide

50 mg

EPD0970000

Dibenzocycloheptene

20 mg

EPD1000000

Dibenzosuberone

EPY0000480

Dibrompropamidine diisetionate

10 mg

EPY0000481

Dibrompropamidine for system suitability

20 mg

EPD1010000

Dibutyl phthalate

EPY0000275

Dichlorodiaminocyclohexaneplatinum

10 mg

EPY0000259

Diclazuril for system suitability

20 mg

EPY0000264

Diclazuril for veterinary use - Reference Spectrum

EPD1039990

Diclofenac potassium

100 mg

EPS0765000

Diclofenac sodium

100 mg

EPD1040000

Diclofenac impurity A 1-(2,6-dichlorophenyl)-indolin-2-one

EPD1050000

Dicloxacillin sodium

250 mg

EPD1060000

Dicycloverine hydrochloride

100 mg

EPY0000439

Didanosine

10 mg

EPY0000440

Didanosine for system suitability

10 mg

EPY0000441

Didanosine impurity A 1,7-dihydro-6H-purin-6-one (hypoxanthine)

10 mg

EPY0000442

Didanosine impurity G 9-(2,3-dideoxy-β-D-glycero-pentofuranosyl)-9H-purin-6-amine (2',3'-dideoxyadenosine)

10 mg

100 mg 5 mg 10 mg 5 mg

100 mg

1 mL

unit

0.005 mg

EPD1200000

Dienestrol

EPD1250000

Diethanolamine fusidate

150 mg

EPD1300000

Diethylcarbamazine citrate

EPY0000217

Diethylene glycol (monoethyl ether) - Reference Spectrum

EPD1410000

Diethyl phthalate

1 mL

EPD1500000

Diethylstilbestrol

100 mg

EPD1600000

Diethylstilbestrol dimethyl ether

10 mg

EPD1700000

50 mg 250 mg unit

Diethylstilbestrol monomethyl ether

10 mg

New EPY0001423

Difloxacin hydrochloride

60 mg

New EPY0001429

Difloxacin impurity G 7-chloro-6-fluoro-1-(4-fluorophenyl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid

15 mg

EPD1750000

Diflunisal

30 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

265

European Pharmacopoeia Code

Product

EPD1800000

Digitoxin

Unit

200 mg

EPY0000640

Digoxigenin

EPD1900000

Digoxin

30 mg

5 mg

EPY0000554

Digoxin for peak identification

10 mg

EPD1940001

Dihydralazine sulphate (hydrated) - Reference Spectrum

EPY0000232

Dihydralazine for system suitability

EPY0000216

Dihydrocodeine hydrogen tartrate - Reference Spectrum

EPY0000053

17 alpha-dihydroequilin

EPD1945000

Dihydroergocristine mesilate

250 mg

EPD1950000

Dihydroergotamine mesilate

100 mg

unit 10 mg unit 10 mg

EPY0000831

Dihydroergotamine for peak identification

EPD1952000

Dihydroergotamine tartrate

EPD1954000

Dihydrostreptomycin sulfate (for LC assay)

25 mg

EPY0000544

Dihydrotachysterol

30 mg

EPY0000482

Dihydrotachysterol for system suitability

EPD1980000

Diltiazem hydrochloride

New EPY0001439

Diltiazem impurity F (2S,3S)-5-[2-(dimethylamino)ethyl]-3-hydroxy-2-(4-methoxyphenyl)-2,3-dihydro-1,5benzothiazepin-4(5H)-one

EPY0001141

Diltiazem for system suitability

EPD2000000

Dimenhydrinate

EPY0000234

N,N-Dimethylacetamide - Reference Spectrum

EPY0001103

Dimenhydrinate for peak identification

10 mg 150 mg

5 mg 300 mg 10 mg

10 mg 100 mg unit 1 mg

EPD2050000

Dimethyl sulfoxide

EPD2200000

Dimeticone

1 mL

EPD2205000

Dimetindene maleate

EPD2255000

Dinoprost trometamol

EPD2250000

Dinoprostone

EPD2250015

Dinoprostone impurity C (E)-7-[(1S,2R,3R)-3-hydroxy-2-[(E)-(3S)-3-hydroxyoct-1-enyl]5-oxocyclopentyl]-hept-5-enoic acid (5-trans-PGE2;(5E)-PGE2)

10 mg

EPY0000094

Diosmin

70 mg

EPY0000095

Diosmin for system suitability

EPD2600000

Diphenhydramine hydrochloride

EPY0000135

Diphenhydramine impurity A 2-(diphenylmethoxy)-N-methylethanamine

EPD2630000

Diphenoxylate hydrochloride - Reference Spectrum

200 mg 50 mg 60 mg 100 mg

5 mg 100 mg 10 mg unit

New EPY0001415

Diphenoxylate hydrochloride Controlled Substance

15 mg

New EPY0001430

Diphenoxylate for system suitability Controlled Substance

10 mg

EPY0000258

Diphtheria toxin BRP

EPD2700000

Diphtheria vaccine (absorbed) BRP

1 mL 32 mg

EPY0000376

Dipivefrine hydrochloride

EPY0000394

Dipivefrine for system suitability

100 mg

EPD2750100

Dipotassium clorazepate - Reference Spectrum

EPD2800000

Diprophylline

100 mg

EPD2850000

Dipyridamole

50 mg

EPY0000802

Dipyridamole for peak identification

EPD2880000

Dirithromycin

100 mg

EPD2900000

Disodium edetate

100 mg

EPD2920000

Disopyramide

100 mg

EPD2922000

Disopyramide phosphate

100 mg

EPD2950000

Disulfiram

100 mg

266

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

10 mg unit

2 mg

Edition 2012/2013

European Pharmacopoeia Code

Product

EPD2953000

Dithranol

55 mg

EPD2953025

Dithranol impurity C Dithranol-dimer 4,4',5,5'-tetrahydroxy-9,9'-bianthracenyl-10,10'(9H,9'H)-dione

20 mg

EPD2953050

Dithranol impurity D 1-hydroxyanthracen-9(10H)-one

20 mg

EPD2954000

Dobutamine hydrochloride

100 mg

EPY0001239

Dobutamine impurity mixture

0.1 mg

Docetaxel impurity E 5ß,20-epoxy-4-(acetyloxy)-1,7ß,10ß,13-tetrahydroxy-9-oxotax-11-en-2-yl benzoate (10-desacetyl-baccatin III)

15 mg

New EPY0001452

Unit

EPY0001133

Docetaxel trihydrate

EPY0001155

Docetaxel for system suitability

10 mg

Anhydrous Docetaxel

15 mg

New EPY0001466 EPD2954600

Docosahexaenoic acid ethyl ester

EPD2954500

Docusate sodium - Reference Spectrum

160 mg

150 mg unit

EPY0000365

Dodecyl gallate

EPD2955000

Domperidone

150 mg

30 mg

EPD2957000

Domperidone maleate

150 mg

EPD2960000

Dopamine hydrochloride

50 mg

EPY0000612

Dopexamine dihydrochloride

10 mg

EPY0000613

Dopexamine impurity B 2-methoxy-4-[2-[[6-[(2-phenylethyl)hexyl]amino]ethyl]phenol

10 mg

EPY0000614

Dopexamine impurity F 4-Chloro-5-[2-[[6-[(2-phenylethyl)amino]hexyl]amino]ethyl]benzene-1,2-diol

10 mg

EPY0000726

Dorzolamide hydrochloride

50 mg

EPY0000727

Dorzolamide impurity A (4R,6R)-4-(ethylamino)-6-methyl-5,6-dihydro-4H-thieno[2,3-b] thiopyran-2-sulphonamide 7,7-dioxide

EPY0000750

Dorzolamide for system suitability

EPD2962000

Dosulepin hydrochloride

EPD2962005

Dosulepin impurity A (E)-3-(6,11-dihydrodibenzo[b,e]thiepin-11-ylidene)N,N'-dimethylpropan-1-amine S-oxide

EPY0001385

Doubleteeth pubescent angelica root

EPD2963000

Doxapram hydrochloride

50 mg

EPY0000208

Doxapram impurity B (4RS)-1-ethyl-4-[2-[(2-hydroxyethyl)amino]ethyl]-3,3-diphenylpyrolidin-2-one

10 mg

EPY0000553

Doxazosin mesilate

60 mg

EPY0000551

Doxazosin impurity D 6,7-dimethoxyquinazoline-2,4(1H,3H)-dione

10 mg

EPY0000552

Doxazosin impurity F 2-chloro-6,7-dimethoxyquinazolin-4-amine

10 mg

5 mg

5 mg 100 mg 50 mg

500 mg

EPY0000838

Doxepin hydrochloride

5 mg

EPY0000851

Doxepin for system suitability

1 mg

EPD2975000

Doxorubicin hydrochloride

EPD3000000

Doxycycline hyclate

EPY0000163

Doxylamine hydrogen succinate - Reference Spectrum

EPY0000160

Doxylamine impurity A N,N-dimethyl-2-[1(RS)-1-phenyl-1-(pyridin-4-yl)ethoxy]ethanamine

EPD3100000

Droperidol

EPY0001105

Drospirenone

EPY0001115

Drospirenone impurity E 3-oxo-6alpha,7alpha,15alpha,16alpha-tetrahydro-3'H,3''H-dicyclopropa [6,7:15,16]pregn-4-ene-21,17-carbolactone (17-epidrospirenone)

0.06 mg

New EPY0001453

Duloxetine hydrochloride

120 mg

New EPY0001454

Duloxetine for system suitability

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

150 mg 50 mg unit 10 mg 150 mg 60 mg

40 mg 267

European Pharmacopoeia Code

Product

EPY0001455

Duloxetine impurity A (3R)-N-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine

10 mg

EPY0001004

Dydrogesterone

50 mg

EPY0001005

Dydrogesterone impurity A 9β,10-pregna-4,6,8(14)-triene-3,20-dione

6 mg

EPY0001006

Dydrogesterone impurity B pregna-4,6-diene-3,20-dione

5 mg

EPY0000249

Ebastine - Reference Spectrum

EPY0000247

Ebastine impurity C 4-(diphenylmethoxy)piperidine

10 mg

EPY0000248

Ebastine impurity D 1-[4-(1,1-dimethylethyl)phenyl]-4-(4-hydroxypiperidin-1-yl)butan-1-one

10 mg

EPY0001236

Econazole

10 mg

EPY0000254

Econazole for system suitability

EPE0050000

Econazole nitrate

100 mg

EPE0085000

Eicosapentaenoic acid ethyl ester

200 mg

EPY0000537

Emedastine difumarate

10 mg

EPY0000512

Emedastine impurity E 1-(2-ethoxyethyl)-2-(hexahydro-1H-1,4-diazepin-1yl)benzimidazole

10 mg

EPE0100000

Emetine hydrochloride

EPE0110000

Enalapril for system suitability

Unit

unit

20 mg

100 mg 20 mg

EPE0109000

Enalapril maleate

EPY0001211

Enalapril impurity mixture

0.06 mg

50 mg

EPY0000615

Enalaprilat dihydrate

100 mg

EPY0000629

Enalaprilat for system suitability

EPY0000678

Enalaprilat impurity G (2SR)-2-[(3SR,8aRS)-3-methyl-1,4-dioxohexahydropyrrolo [1,2-a]pyrazin-2(1H)-4-phenylbutanoic acid

10 mg 0.005 mg

EPY0000136

Enilconazole

60 mg

EPY0000137

Enilconazole impurity E (1RS)-1-(2,4-dichlorophenyl)-2-(-1H-imidazol-1-yl)ethanol

20 mg

EPE0150000

Endotoxin standard BRP

10 mg

EPE0180000

Enoxaparin sodium

200 mg

EPE0180500

Enoxolone

100 mg

EPY0001259

Enrofloxacin

EPY0001160

Enrofloxacin for system suitability

EPY0001249

Entacapone

EPY0001250

Entacapone impurity A Z isomer of entacapone

EPE0200000

Enterokinase BRP

EPE0305000

Ephedrine hydrochloride (racemic) Drug Precursor

5 mg 10 mg 160 mg 10 mg 200 mg 50 mg

EPE0300000

Ephedrine hydrochloride Drug Precursor

EPE0400000

4-Epianhydrotetracycline hydrochloride

150 mg 20 mg

EPE0440000

4-Epidemeclocycline hydrochloride

20 mg

EPE0500000

6-Epidoxycycline hydrochloride

50 mg

EPY0001139

Epinastine hydrochloride

20 mg

EPY0001128

Epinastine hydrochloride for system suitability

10 mg

EPE0530000

4-Epioxytetracycline

40 mg

EPE0550000

Epirubicin hydrochloride

EPE0600000

4-Epitetracycline hydrochloride

100 mg 30 mg

EPY0000052

Equilin

EPE0850010

Eq influenza Subtype 1 Strain A/eq/Newmarket/77 Horse Antiserum BRP

3x1 mg

15 mg

EPE0850021

Eq influenza Subtype 2 American-like/Newmarket Horse Antiserum BRP

3x1 mg

EPE0850022

Eq Influenza Subtype 2 European-like/Newmarket Horse Antiserum BRP

3x1 mg

268

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia Code

Product

EPY0000712

Eq Influenza Subtype 2 American-like/South Africa Horse Antiserum BRP

3x1 mg

Equisetum palustre

200 mg

Ergocalciferol

500 mg

New EPY0001325 EPE0900000

Unit

EPE1000000

Ergometrine maleate Drug Precursor

50 mg

EPE1100000

Ergosterol

20 mg

EPE1200000

Ergotamine tartrate Drug Precursor

EPY0000051

Erysipelas ELISA coating antigen BRP

EPY0000177

Erythritol

EPE1300000

Erythromycin for microbiological assay

250 mg

EPE1305000

Erythromycin A

250 mg

EPE1310000

Erythromycin B

50 mg

EPE1320000

Erythromycin C

50 mg

EPE1400000

Erythromycin estolate

100 mg 0.4 mg 1000 mg

100 mg

EPE1500000

Erythromycin ethylsuccinate

10 mg

EPE1500800

Erythromycin stearate

50 mg

EPE1515000

Erythropoietin BRP

EPY0000324

Esketamine hydrochloride - Reference Spectrum

EPY0000338

Esketamine impurity D (2R)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone ((R)-ketamine)

EPY0001028

Esomeprazole magnesium trihydrate

EPY0000749

Essential oil

37.5 mg unit 10 mg 10 mg 1000 mg

EPE1600000

Estradiol benzoate

EPY0000852

Estradiol benzoate for system suitability

250 mg 10 mg

EPY0000045

Estradiol butyrate

10 mg

EPE1620000

Estradiol hemihydrate

EPY0000314

Estradiol for peak identification

100 mg 10 mg

EPY0000046

Estradiol valerate

50 mg

EPE1680000

Estriol

50 mg

EPE1680005

Estriol impurity A 9,11-didehydroestriol

20 mg

EPE1700000

Estrone

EPE1800000

Etacrynic acid

EPY0001263

Etacrynic acid for system suitability

15 mg 100 mg 10 mg

EPE1830000

Etamsylate

30 mg

EPE1840000

Ethacridine lactate monohydrate

50 mg

EPE1850000

Ethambutol hydrochloride

EPY0000803

Ethambutol for system suitability

250 mg

EPA1202800

Ethanol (anhydrous) - Reference Spectrum

unit

EPE1860100

Ethanol 96% - Reference Spectrum

unit

EPE1900000

Ethinylestradiol

EPY0001124

Ethinylestradiol for system suitability

EPE2000000

Ethionamide

10 mg

200 mg 25.31 mg 100 mg

EPE2150000

Ethosuximide

30 mg

EPE2250000

Ethosuximide impurity A (2RS)-2-ethyl-2-methylbutanedioic acid

30 mg

EPE2195000

Ethyl acetate - Reference Spectrum

EPE2195900

Ethylcellulose - Reference Spectrum

EPE2202000

1-N-Ethylgaramin sulfate

EPE2205500

1,1'-Ethylidenebistryptophan

EPY0000617

Ethyl indole-3-carboxylate

EPE2300000

Ethylmorphine hydrochloride - Reference Spectrum

EPE2400000

Ethylnicotinamide

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

unit unit 50 mg 2x0.00167 mg 10 mg unit 150 mg 269

European Pharmacopoeia Code

Product

EPE2425000

Ethyl parahydroxybenzoate

Unit

150 mg

EPE2450000

Etifenin

25 mg

EPE2451000

Etilefrine hydrochloride

75 mg

EPE2451010

Etilefrine impurity A 2-ethylamino-1-(3-hydroxyphenyl)ethanone

20 mg

EPY0000572

Etidronate disodium

10 mg

EPE2470000

Etodolac

60 mg

EPE2470050

Etodolac impurity H 2-(7-ethylindol-3-yl)ethanol

10 mg

EPY0000768

Etodolac for peak identification

10 mg

EPE2499900

Etofenamate

40 mg

EPE2499901

Etofenamate for peak identification

15 mg

EPE2499914

Etofenamate impurity G 2-hydroxyethyl 2-[[3-(trifluoromethyl)phenyl]amino]-benzoate

20 mg

EPE2500000

Etofylline

100 mg

EPE2503000

Etomidate

50 mg

EPE2503004

Etomidate impurity B methyl 1-[(1RS)-1-phenylethyl]-1H-imidazole-5-carboxylate

25 mg

EPE2600000

Etoposide

EPY0001365

Etoposide for system suitability

150 mg 10 mg

EPE5000000

Eugenol

500 µL

EPF0005000

Famotidine

100 mg

EPY0000382

Famotidine for system suitability

10 mg

EPY0000409

Famotidine impurity D 3-[[[2-[(diaminomethylene)amino]thiazol-4-yl]methyl]sulphanyl]propanamide

10 mg

EPY0000556

Febantel

EPY0000660

Febantel for system suitability

10 mg

EPY0000731

Felbinac

10 mg

EPY0000732

Felbinac impurity A 4-acetyl biphenyl

20 mg

EPF0030000

Felodipine

110 mg

120 mg

EPY0000415

Felypressin

EPF0040000

Fenbendazole

0.994 mg

EPF0040010

Fenbendazole impurity A methyl(1H-benzimidazol-2-yl)carbamate

20 mg

EPF0040020

Fenbendazole impurity B methyl[5(6)-chlorobenzimidazol-2-yl]carbamate

20 mg

150 mg

EPF0041000

Fenbufen

100 mg

EPF0048000

Fenofibrate

100 mg

EPF0048005

Fenofibrate impurity A (4-chlorophenyl)(4-hydroxyphenyl)methanone

20 mg

EPF0048010

Fenofibrate impurity B 2[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid (fenofibric acid)

10 mg

EPF0048035

Fenofibrate impurity G 1-methylethyl 2-[[2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoyl] oxy]-2-methylpropanoate

25 mg

EPY0000756

Fenoterol for peak identification

1.2 mg

EPF0050000

Fenoterol hydrobromide

100 mg

EPF0054990

Fentanyl - Reference Spectrum

New EPY0001509

Fentanyl for system suitability Controlled Substance

unit 25 mg

EPF0055000

Fentanyl citrate - Reference Spectrum

unit

EPF0060000

Fenticonazole nitrate

50 mg

EPF0060040

Fenticonazole impurity D (RS)-1-[2-(2,4-dichlorophenyl)-2-hydroxyethyl]-3[4-(phenyl suphanyl)benzyl]imidazolium nitrate

20 mg

270

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia Code

Product

EPF0100000

Ferrous gluconate

Unit

100 mg

EPY0001013

Ferulic acid

20 mg

EPY0000789

Fexofenadine hydrochloride

60 mg

EPY0000751

Fexofenadine impurity A 2-[4-[4-[4-(hydroxydiphenylmethyl)piperidin-1-yl] butanoyl]phenyl]-2-methylpropanoic acid

EPY0000752

Fexofenadine impurity B 2-[3-[(1RS)-1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl]phenyl]-2methylpropanoic acid

EPY0000753

Fexofenadine impurity C (1RS)-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]-1-[4-(1-methylethyl)phenyl]butan-1-ol

5 mg

0.01 mg

5 mg

EPY0001173

Filgrastim

0.2 mL

EPY0000090

Finasteride

60 mg

EPY0000091

Finasteride for system suitability

EPY0000736

Flavoxate hydrochloride

10 mg

EPY0000737

Flavoxate impurity A 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylic acid

10 mg

EPY0000738

Flavoxate impurity B ethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate

10 mg

EPF0120000

Flecainide acetate

EPF0120005

Flecainide impurity A 3-[2,5-bis(2,2,2-trifluoroethoxy)phenyl]-1,5,6,7,8,8ahexahydroimidazo[1,5-a]pyridine

50 mg

EPF0120010

Flecainide impurity B (RS)-(piperidin-2-yl)methanamine

25 mg

EPY0001274

Flecainide for system suitability

10 mg

EPY0000138

Flubendazole

25 mg

EPY0000139

Flubendazole for system suitability

20 mg

EPY0000892

Flucloxacillin magnesium octahydrate

5 mg

EPY0000889

Flucloxacillin impurity C 6-aminopenicillanic acid

5 mg

EPY0000890

Flucloxacillin impurity D 3-(2-chloro-6-fluorophenyl)-5-methylisoxazole-4-carboxylic acid

5 mg

EPY0000891

Flucloxacillin impurity E 6-aminopenicillanic acid flucloxacillin amide

5 mg

100 mg

200 mg

EPF0150000

Flucloxacillin sodium

EPY0000557

Fluconazole

250 mg 50 mg

EPY0000558

Fluconazole for peak identification

10 mg

EPY0000573

Fluconazole impurity B 2-[2-fluro-4-(1H-1,2,4-triazol-1-yl)phenyl]-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol

10 mg

EPY0000574

Fluconazole impurity C 1,1´-(1,3-phenylene)di-1H-1,2,4-triazole

EPF0175000

Flucytosine

EPY0001262

Flucytosine for system suitability

EPY0000419

Fludarabine phosphate

120 mg

EPF0180000

Fludrocortisone acetate

100 mg

EPF0188000

Flumazenil - Reference Spectrum

EPY0000335

Flumazenil impurity B ethyl 8-hydroxy-5-methyl-6-oxo-5,6-dihydro-4H-imidazo [1,5-a][1,4]benzodiazepine-3-carboxylate

EPF0189000

Flumequine

60 mg

EPF0189020

Flumequine impurity B ethyl(RS)-9-fluoro-5-methyl-1-oxo-6,7-dihydro-1H,5H-benzo[i,j] quinolizine-2-carboxylate

0.1 mg

EPF0188500

Flumetasone pivalate

100 mg

EPF0189900

Flunarizine dihydrochloride

100 mg

EPY0000265

Flunarizine dihydrochloride - Reference Spectrum

unit

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

271

5 mg 100 mg 10 mg

unit 5 mg

European Pharmacopoeia Code

Product

EPY0000266

Flunarizine dihydrochloride for system suitability

EPF0190000

Flunitrazepam Controlled Substance

EPY0000169

Flunitrazepam - Reference Spectrum

Unit

20 mg 100 mg unit

EPY0000443

Flunixin meglumine

10 mg

EPY0000444

Flunixin impurity B 2-methyl-3-(trifluoromethyl)aniline

10 mg

EPY0000445

Flunixin impurity C ethyl 2-chloropyridine-3-carboxylate

50 mg

EPF0200000

Fluocinolone acetonide

100 mg

EPF0230000

Fluocortolone pivalate

100 mg

EPY0000796

Fluorescein

120 mg

EPY0000804

Fluorescein impurity C 2-(2,4-dihydroxybenzoyl)benzoic acid

0.01 mg

EPY0000454

Diacetylfluorescein

100 mg

EPF0245000

Fluoresceine sodium - Reference Spectrum

EPF0250000

Fluorouracil

40 mg

EPY0000762

Fluorouracil impurity A pyrimidine-2,4,6(1H,3H,5H)-trione (barbituric acid)

10 mg

EPY0000763

Fluorouracil impurity B dihydropyrimidine-2,4,5(3H)-trione (isobarbituric acid or 5-hydroxyuracil)

10 mg

EPY0000764

Fluorouracil impurity C pyrimidine-2,4(1H,3H)-dione (uracil)

10 mg

EPY0000765

Fluorouracil impurity F 2-ethoxy-5-fluoropyrimidin-4(1H)-one (2-ethoxy-5-fluorouracil)

10 mg

EPY0000791

Fluorouracil impurity mixture

EPF0253000

Fluoxetine hydrochloride

EPF0253020

Fluoxetine impurity B methyl(3-phenylpropyl)amine Controlled Substance

EPF0253030

Fluoxetine impurity C (RS)-methyl-[3-phenyl-3-(3-trifluoromethylphenoxy)-propyl]amine

EPY0000064

Flupentixol dihydrochloride

EPY0000067

Flupentixol impurity D 2-[2-[4-[3-[(EZ)-2-(trifluoromethyl)-9H-thioxanthen-9-ylidene]propyl] piperazin-1-yl]ethoxy]ethanol

15 mg

EPY0000078

Flupentixol impurity F 2-[4-[(EZ)-3-[(9RS)-2-(trifluoromethyl)-9H-thioxanthen-9-yl)prop-2-enyl]piperazin-1-yl]ethanol

25 mg

EPF0260000

Fluphenazine decanoate

EPY0000009

Fluphenazine enantate

EPF0280000

Fluphenazine dihydrochloride

50 mg

EPY0000708

Fluphenazine impurity mixture

0.07 mg

EPY0000298

Fluphenazine octanoate

20 mg

EPY0000299

Fluphenazine sulphoxide

10 mg

EPY0000211

Flurazepam monohydrochloride - Reference Spectrum

EPF0285200

Flurbiprofen

50 mg

EPF0285202

Flurbiprofen impurity A (2RS)-2-(biphenyl-4-yl)propanoic acid

20 mg

EPY0000236

Fluspirilene

20 mg

EPY0000375

Fluspirilene impurity C 8-[4,4-bis((4-fluorophenyl)butyl]-3-(hydroxymethyl)-1phenyl-1,3,8-triazaspiro[4.5]decan-4-one

10 mg

EPF0285600

Flutamide

50 mg

EPF0285603

Flutamide impurity C N-[4-nitro-3-(trifluoromethyl)phenyl]propanamide

20 mg

EPY0000284

Fluticasone propionate

272

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

unit

0.0002 mg 250 mg 10 mg 5 mg 100 mg

60 mg 100 mg

unit

100 mg

Edition 2012/2013

European Pharmacopoeia Code

Product

EPY0000221

Fluticasone impurity D S-methyl 6a,9a-difluoro-11b-hydroxy-16a-methyl-3-oxo-17a-propionyloxy-androsta1,4-diene-17β-carbothioate (S-methyl derivative)

Unit

EPF0290000

Flutrimazole

EPF0290010

Flutrimazole impurity B (RS)-(2-fluorophenyl)(4-fluorophenyl)phenylmethanol

EPY0001090

Fluvastatin sodium

110 mg

EPY0001082

Fluvastatin for system suitability

0.5 mg

EPY0000854

Fluvoxamine maleate

EPY0000853

Fluvoxamine for system suitability

EPY0000916

Fluvoxamine impurity D 5-methoxy-1-[4-(trifluoromethyl)phenyl]pentan-1-one

EPY0000386

Foeniculin for peak identification Anise oil

EPF0300000

Folic acid

EPY0001242

Folic acid impurity A (2S)-2-[(4-aminobenzoyl)amino]pentanedioic acid (N-(4-aminobenzoyl)-l-glutamic acid)

15 mg

EPY0001243

Folic acid impurity D 4-[[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino]benzoic acid (pteroic acid)

70 mg

EPF0372000

Formoterol fumarate dihydrate

10 mg

20 mg

100 mg 60 mg

5 mg 1.004 mg 10 mg 100 mg 2x150mg

EPY0000339

Formoterol for impurity I identification

10 mg

EPY0000340

Formoterol fumarate for system suitability

10 mg

EPF0380000

Formylfolic acid 10-Formylfolic acid

30 mg

EPF0389000

Foscarnet sodium hexahydrate

50 mg

EPF0389004

Foscarnet impurity B disodium(ethoxyoxydophosphanyl)formate

10 mg

EPY0001222

Foscarnet impurity D Ethyl (diethoxyphosphinyl)formate

50 mg

EPY0001213

Foscarnet impurity mixture

0.012 mg

EPY0000782

Fosfomycin calcium

EPF0399950

Fosfomycin sodium - Reference Spectrum

10 mg

EPF0400000

Fosfomycin trometamol

EPY0001227

Fosinopril sodium

EPY0001228

Fosinopril impurity A (2S,4S)-4-cyclohexyl-1-[[(R)-hydroxy(4-phenylbutyl)phosphoryl] acetyl]pyrrolidine-2-carboxylic acid

5 mg

EPY0001229

Fosinopril impurity B (2RS,4RS)-4-cyclohexyl-1-[[(RS)-[(1SR)-2-methyl-1-(1-oxopropoxy)propoxy](4phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic acid

5 mg

EPY0001230

Fosinopril impurity C mixture of (2S,4S)-4-cyclohexyl-1-[[(S)-[(1S)-2-methyl-1-(1-oxopropoxy)propoxy](4phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic acid and (2S,4S)-4-cyclohexyl-1-[[(R)[(1R)-2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphoryl]acetyl]pyrrolidine-2carboxylic acid

10 mg

EPY0001231

Fosinopril impurity D (2S,4R)-4-cyclohexyl-1-[[(R)-[(1S)-2-methyl1-(1-oxopropoxy)propoxy](4-phenylbutyl) phosphoryl]acetyl]pyrrolidine-2-carboxylic acid

10 mg

EPY0001232

Fosinopril impurity I [(RS)-[(1SR)-2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl) phosphoryl]acetic acid

5 mg

EPY0001233

Fosinopril impurity K (2S,4S)-4-cyclohexyl-1-(2,2-dimethyl-1-oxopropyl) pyrrolidine-2-carboxylic acid

5 mg

unit 1500 mg 60 mg

EPY0001212

Fosinopril impurity mixture

0.02 mg

EPF0450000

Framycetin sulphate

2x25 mg

EPF0550000

Fructose

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg

273

European Pharmacopoeia Code

Product

New EPY0001399

Fulvestrant

New EPY0001413

Fulvestrant for system sitability

EPF0600000 EPF0700000 New EPY0001493 EPF0702000 New EPY0001411 EPF1000000

Unit

120 mg 40 mg

Fumaric acid

120 mg

Furosemide

100 mg

Furosemide for peak identification Furosemide impurity A 2-chloro-4-(furfurylamino)-5-sulphamoylbenzoic acid Fusidic acid Fusidic acid - Reference Spectrum

New EPY0001394

Fusidic acid for peak identification

New EPY0001384

Fusidic acid impurity mixture

10 mg 5 mg 10 mg unit 5 mg 0.0475 mg

EPY0001280

Gabapentin

300 mg

EPY0001281

Gabapentin impurity A 2-azaspiro[4.5]decan-3-one

20 mg

EPY0001348

Gabapentin impurity B (1-cyanocyclohexyl)acetic acid

20 mg

EPY0001349

Gabapentin impurity D [1-[(3-oxo-2-azaspiro[4.5]dec-2-yl)methyl]cyclohexyl]acetic acid

10 mg

EPG0049000

Galactitol

50 mg

EPG0050000

Galactose

60 mg

EPY0001279

Galantamine hydrobromide

10 mg

EPY0001190

Galantamine natural for system suitability

10 mg

EPY0001201

Galantamine racemic mixture

10 mg

EPY0001191

Galantamine synthetic for system suitability

EPG0100000

Gallamine triethiodide

EPG0150000

Gammacyclodextrin

EPY0001129

Ganciclovir

EPY0001144

Ganciclovir impurity mixture

EPY0000675

Gemcitabine hydrochloride

50 mg

EPY0000676

Gemcitabine impurity A 4-aminopyrimidin-2(1H)-one (Cytosine)

20 mg

EPY0000513

Gemfibrozil

EPY0000514

Gemfibrozil for system suitability

5 mg 100 mg 50 mg 220 mg 0.005 mg

5 mg 0.196 mg

EPG0200000

Gentamicin sulphate

EPY0001363

Gentamicin for peak identification

2x25 mg

EPY0001112

Gestodene

EPY0001110

Gestodene for system suitability

EPY0001116

Gestodene impurity I 13-ethyl-17-hydroxy-5-methoxy-18,19-dinor-5alpha,17alpha-pregn-15-en-20-yn-3-one

0.01 mg

EPY0001012

Ginkgo dry extract for peak identification

150 mg

10 mg 100 mg 10 mg

EPY0001010

Ginkgolic Acid

20 mg

EPG0300000

Gitoxin

30 mg

EPG0325000 New EPY0001511

Glibenclamide

100 mg

Glibenclamide for peak identification

30 mg

EPG0325010

Glibenclamide impurity A 4-[2-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulphonamide

10 mg

EPY0000242

Glibenclamide impurity B methyl [[4-[2-[(5-chloro-2-methoxybenzoyl)amino]ethyl]phenyl] sulphonyl]carbamate

20 mg

EPG0326000

Gliclazide

20 mg

EPG0326004

Gliclazide impurity B 2-nitroso-octahydrocyclopenta[c]pyrrole

25 mg

EPG0326012

Gliclazide impurity F 1-(hexahydrocyclopenta[c]pyrrol-2-(1H)-yl-3-[(2-methylphenyl)sulphonyl]urea

50 mg

EPY0000515

Glimepiride

60 mg

274

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia Code

Product

EPY0000516

Glimepiride for system suitability

Unit

0.012 mg

EPG0340000

Glipizide

50 mg

EPG0342000

Glipizide impurity A 4-[2-(5-methylpyrazine-2-carboxamido)ethyl]benzene sulphonamide

10 mg

EPY0000523

Glipizide impurity C ethyl 2-[4-[(cyclohexylcarbamoyl)sulphamoyl]phenyl]ethyl]carbamate

10 mg

EPY0000643

Glipizide impurity D 6-methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyrazine-2-carboxamide

10 mg

EPY0001140

Glipizide impurity mixture

0.002 mg

EPY0000191

Human glucagon

2x2.94mg

New EPY0001406

Glucosamine hydrochloride

10 mg

New EPY0001381

Glucosamine for system suitability

40 mg

New EPY0001407

Glucosamine sulfate sodium chloride

15 mg

EPG0350500

Glucose

EPG0355000

Glutamic acid

50 mg

EPY0000517

Glutathione

10 mg

EPG0360000

Glutethimide Controlled Substance

50 mg

EPG0400000

Glycerol (85 per cent) - Reference Spectrum

EPG0400004 New EPY0001391

100 mg

unit

Glycerol distearate

2000 mg

Glycerol formal

2x20 mg

EPY0000794

Glycerol monocaprylate

400 mg

EPY0000795

Glycerol monocaprylocaprate

500 mg

EPG0400006

Glycerol monolinoleate

2000 mg

EPG0400007

Glycerol mono-oleate

2000 mg

EPG0400008

Glycerol monostearate 40-55

2000 mg

EPG0400101

Glyceryl trinitrate - Reference Spectrum

EPG0400100

Glyceryl trinitrate solution

0.5 mL

EPG0450000

Glycine

50 mg

EPY0001308

Glycopyrronium bromide

10 mg

EPY0001309

Glycopyrronium for peak identification

10 mg

EPY0001358

Glycopyrronium impurity N (3RS)-3-[(2RS)-(2-cyclopentyl-2-hydroxy-2-phenylacetyl)oxy]-1,1-dimethylpyrrolidinium

10 mg

EPY0000433

Ammonium glycyrrhizate

EPG0460000

Glycyrrhizate (monoammonium)

unit

70 mg 300 mg

EPG0525000

Gonadorelin

5 mg

EPY0000125

Goserelin

2 mg

EPY0000126

Gosereline - Reference Spectrum

New EPY0001473

unit

Goserelin for NMR identification

14 mg

EPY0000019

4-D-Ser-goserelin

0.1 mg

EPY0000194

Goserelin validation mixture

EPG0550000

Gramicidin

250 mg

EPY0000396

Granisetron hydrochloride

120 mg

EPY0000477

Granisetron impurity A 2-methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1] non-3-yl]-2H-indazole-3-carboxamide

1 mg

EPY0000478

Granisetron impurity B N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide

1 mg

EPY0000395

Granisetron impurity E (1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]nonan-3-amine

EPG0600000

Griseofulvin

EPY0000619

Guaiacol

1 mg

2x15 mg 50 mg 2200 mg

EPG0700000

Guaifenesin

100 mg

EPY0000117

Halofantrine hydrochloride

125 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

275

European Pharmacopoeia Code

Product

EPY0000118

Halofantrine impurity C [1,3-dichloro-6-(trifluoromethyl)phenantren-9-yl]methanol

10 mg

Unit

EPH0100000

Haloperidol

50 mg

New EPY0001517

Haloperidol for system suitability

25 mg

New EPY0001518

Haloperidol for peak identification

25 mg

EPH0100100

Haloperidol decanoate

60 mg

EPH0150000

Halothane - Reference Spectrum

unit

EPY0000673

Harpagoside

EPY0001287

Heparin calcium for NMR identification

1.03 mg 30 mg

EPY0001282

Heparin for Physio-Chemical Analysis

300 mg

EPH0185000

Heparin Low-Molecular-Mass for assay BRP

5x1 mg

EPH0190000

Heparin Low-Molecular-Mass for calibration CRS

25 mg

EPH0200000

Heparin sodium BRP

EPY0001283

Heparin sodium for NMR identification

EPH0205010

Hepatitis A vaccine (inactivated,absorbed) Type B BRP

3x0.5 mL

EPY0001192

Hepatitis A Vaccine (Inactivated, Non-Adsorbed)

3x0.8 mL

EPY0000389

Hepatitis B vaccine (rDNA) BRP method A (thiomersal free)

2x0.5 mL

EPH0210010

Hepatitis B vaccine (rDNA) BRP method B

2x1 mL

EPH0215000

Hepatitis C Virus RNA for NAT testing BRP

5x40 mg

EPH0220000

Heptadecanol

EPY0000063

Heptaminol hydrochloride

EPY0000057

Heptaminol impurity A (2RS)-6-methylhept-5-en-2-amine

20 mg

EPH0250000

alpha-Hexachlorocyclohexane

10 mg

EPH0330000

Hexamidine diisetionate

50 mg

EPH0325000

Hexetidine

100 mg

EPH0400000

Hexobarbital

500 mg

EPH0420000

Hexylresorcinol

100 mg

EPH0500000

Hide Powder

500 mg

EPH0600000

Histamine dihydrochloride

250 mg

EPH0700000

Histamine phosphate

250 mg

EPH0750000

Histidine

100 mg

EPH0755000

Histidine hydrochloride monohydrate

100 mg

EPH0800000

Homatropine hydrobromide

100 mg

EPH0830000

Homatropine methylbromide

25 mg

New EPY0001383

Homatropine methylbromide for system suitability

EPH0837000

L-Homocycsteine thiolactone hydrochloride - Reference Spectrum

EPH0900000

Human albumin for electrophoresis BRP

EPY0000219

Human anti-D immunoglobulin BPR

2 mL 30 mg

2x600 mg 150 mg

5 mg unit 1 mL unit

EPY0000667

Human coagulation factor VII concentrate BRP

2x26 mg

EPH0920000

Human coagulation factor VIII concentrate BRP

5x37 mg

EPH0920500

Human coagulation factor IX concentrate BRP

5x30 mg

EPH0950000

Human hepatisis A immunoglobulin BRP

EPH0990000

Human immunoglobulin BRP

EPH1000000

Human immunoglobulin for electrophoresis BRP

EPY0000488

Human immunoglobulin (molecular size) BRP

EPH1005000

Human Plasma Pools for NAT Validation

EPH1100000

Human rabies immunoglobulin BRP

EPH1110000

Human tetanus immunoglobulin BRP

EPY0000502

Human vaccinia immunoglobulin

EPH1115000

Hyaluronidase BRP

276

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

3x10 mg 15800 mg 96 mg 3x700 mg 3502 mg 3x170 mg 87 mg 3x1 mL 50 mg

Edition 2012/2013

European Pharmacopoeia Code

Product

EPH1120000

Hydralazine hydrochloride

EPY0001151

Hydrastine hyrochloride

EPH1200000

Hydrochlorothiazide

New EPY0001494

Unit

20 mg 20 mg 160 mg

Hydrochlorothiazide for peak identification

10 mg

EPY0000646

Hydrocodone hydrogen tartrate 2.5-hydrate Controlled Substance

10 mg

EPY0000710

Hydrocodone for peak identification Controlled Substance

10 mg

EPH1300000

Hydrocortisone

EPY0001092

Hydrocortisone for peak identification

EPH1400000

Hydrocortisone acetate

New EPY0001482

Hydrocortisone acetate for peak identification

100 mg 5 mg 125 mg 15 mg

EPH1425000

Hydrocortisone hydrogen succinate

100 mg

EPH1426000

Hydrogenated wool fat

250 mg

EPY0000446

Hydromorphone hydrochloride Controlled Substance

EPB0650000

Hydrous benzoyl peroxide - Reference Spectrum

EPH1428000

Hydroxocobalamin

10 mg

EPY0000119

Hydroxycarbamide

175 mg

EPH1429400

Hydroxyethyl salicylate

125 mg

10 mg unit

EPY0001322

Hydroxyethyl starch (high Mw)

EPY0001277

Hydroxyethyl starch (medium MW)

800 mg

EPH1429700

4-Hydroxyphenoxymethylpenicillin potassium

20 mg

EPH1430000

D-alpha-(4-Hydroxy-phenyl)glycine (2R)-2-amino-2-(4-hydroxyphenyl)acetic acid - Cefadroxyl impurity A

50 mg

EPY0000186

Hydroxypropylbetadex

10 mg

EPH1435000

Hydroxyzine hydrochloride

600 mg

EPY0000011

Hymecromone

100 mg

EPY0000012

Hymecromone impurity A Resorcinol

25 mg

EPY0000013

Hymecromone impurity B 7-hydroxy-2-methyl-4H-1-benzopyran-4-one

25 mg

EPY0000483

Hyoscine

10 mg

EPY0000484

Hyoscine impurity A (1R,2R,4S,5S,7s)-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl (2S)-3-hydroxy-2phenylpropanoate (norhyoscine)

10 mg

EPH1450000

Hyoscine butylbromide

20 mg

EPY0000447

Hyoscine butylbromide impurity E (1R,2R,4S,5S,7S)-9-butyl-7-[[(2S)-3-hydroxy-2-phenylpropanoyl]oxy]-3-oxa9-azoni atricyclo[3.3.1.02,4]nonane

10 mg

EPH1500000

Hyoscine hydrobromide

50 mg

EPY0000448

Hyoscine hydrobromide impurity B (1R,2R,4S,5S,7s)-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl(2S)3-hydroxy-2-phenylpropanoate

10 mg

EPH1600000

Hyoscyamine sulfate

EPY0000449

Hyoscyamine impurity E (1R,3s,5S)-8-azabicyclo[3.2.1] oct-3-yl(2S)-3-hydroxy-2-phenylpropanoate

10 mg

EPY0000915

Hypromellose phthalate

10 mg

EPI0020000

Ibuprofen

250 mg

EPB1220000

Ibuprofen impurity B (2RS)-2-(4-Butylphenyl)propionic acid (0,06% solution in Acetonitrile)

1.15 mL

EPY0000140

Ibuprofen impurity F 3-[4-(2-methylpropyl)phenyl]propanoic acid

EPY0000881

Ibuprofen for peak identification

EPI0050000

Idoxuridine

50 mg

EPI0060000

Ifosfamide

50 mg

EPI0060100

Ifosfamide - Reference Spectrum

unit

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

277

1200 mg

100 mg

5 mg 0.09 mg

European Pharmacopoeia Code

Product

EPI0060002

Ifosfamide impurity A 3-[(2-chloroethyl)amino]propyl dihydrogen phosphate

EPI0060004

Ifosfamide impurity B bis[3-[(2-chloroethyl)amino]propyl]dihydrogen diphosphate

EPI0060010

Ifosfamide impurity E 3-chloro-N-(2-chloroethyl)propan-1-amine

EPI0060012

Ifosfamide impurity F (RS)-2-chloro-3-(2-chloroethyl)-1,3,2-oxazaphosphinane 2-oxide

Unit

2x100 mg 20 mg 2x10 mg 10 mg

EPI0086000

Imidazole

100 mg

EPI0090000

Imipenem

100 mg

EPI0100000

Imipramine hydrochloride

EPY0000893

Imipramine for system suitability

10 mg

EPY0001153

Immunoglobulin for anti-A, anti-B antibodies limit test

45 mg

50 mg

EPY0000540

Immunoglobulin panel for anti-D antibodies test BRP

EPY0001205

Imperatorin

20 mg

unit

EPI0150000

Indapamide

150 mg

EPI0150020

Indapamide impurity B 4-chloro-N-(2-methyl-1H-indol-1-yl)-3-sulphamoylbenzamide

EPY0000788

Indinavir

EPY0000880

Indinavir sulfate - Reference Spectrum

EPY0000746

Indinavir for system suitability

20 mg

EPI0200000

Indometacin

50 mg

EPY0000349

Insulin aspart

EPI0305000

Insulin (bovine)

EPI0310000

Insulin (human)

EPY0000348

Insulin lispro

5.93 mg

EPI0320000

Insulin (porcine)

8.61mg

EPI0320300

Interferon alfa-2a

1 mL

EPI0320301

Interferon alfa-2b

200 µL

EPY0001101

Interferon beta-1a

EPI0320330

Interferon gamma 1b

EPI0320331

Interferon gamma-1b validation solution

0.2 mL

EPI0328000

Iobenguane sulfate

25 mg

EPY0000839

Iobenguane sulphate - Reference Spectrum

EPY0001294

Iodixanol

60 mg

EPY0001292

Iodixanol impurity C 5-[acetyl[3-[[3,5-bis[(2,3-dihydroxypropyl)carbamoyl]-2,4,6-triiodophenyl]amino]-2hydroxypropyl]amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide

10 mg

EPY0001291

Iodixanol impurity E 5-[acetyl[3-[acetyl[3-carbamoyl-5-[(2,3-dihydroxypropyl)carbamoyl]-2,4,6triiodophenyl]amino]-2-hydroxypropyl]amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6triiodobenzene-1,3-dicarboxamide

10 mg

EPY0001293

Iodixanol impurity H 5-[acetyl[3-[acetyl[3-[[3-[3-[acetyl[3,5-bis[(2,3-dihydroxypropyl)carbamoyl]-2,4,6triiodophenyl]amino]-2-hydroxypropoxy]-2-hydroxypropyl]carbamoyl]-5-[(2,3dihydroxypropyl)carbamoyl]-2,4,6-triiodophenyl]amino]-2-hydroxypropyl]amino]-N,N'-bis(2,3dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide

10 mg

5 mg 100 mg unit

8 mg 7.99 mg 8 mg

0.5 mL 2x0.5 mL

unit

EPI0320800

Iohexol

EPI0320810

Iohexol impurity A 5-acetamido-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-tri-iodobenzene-1,3- dicarboxamide

150 mg

EPI0320820

Iohexol impurity J 5-amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-tri-iodobenzene-1,3-dicarboxamide

EPY0000672

Iohexol for peak identification

10 mg

EPI0329000

Iopamidol

50 mg

EPI0329010

Iopamidol impurity A N,N'-bis[2-hydroxy-1-(hydroxymethyl)ethy]-5-amino-2,4,6-tri-iodoisophthalamide

10 mg

278

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

50 mg 125 mg

European Pharmacopoeia Code

Product

EPY0000406

Iopamidol impurity H 4-chloro-N,N'-bis(2-hydroxy-1-(hydroxymethyl)ethyl)-5(2-hydroxypropanoyl)amino)2,6-diiodobenzenz-1,3-dicarboxamide

EPI0330000

Iopanoic acid

EPY0001297

Iopentol

EPY0001020

Iopromide

EPY0001077

Iopromide impurity A 5-amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-N-methylbenzene-1,3- dicarboxamide

EPY0001021

Iopromide for system suitability 1

EPY0001022

Iopromide for system suitability 2

EPI0340000

Iotalamic acid

EPA0560000

Iotalamic acid impurity A 5-Amino-2,4,6-tri-iodo-N-methylisophthalamic acid

EPY0000555

Iotrolan

EPY0000658

Iotrolan for system suitability

Unit

10 mg

100 mg 10 mg 100 mg 0.125 mg 5 mg 5 mg 150 mg 20 mg 100 mg 5 mg

EPY0000141

Ioxaglic acid

EPY0000142

Ioxaglic acid impurity A 3-amino-5-[(2-hydroxyethyl)carbamoyl]-2,4,6-triiodobenzoic acid

125 mg

EPI0360000

Ipratropium bromide

EPY0000276

Ipratropium impurity A (1R,3r,5S,8r)-3-hydroxy-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane

10 mg

EPI0361000

Ipratropium bromide impurity B (1R,3r,5S,8s)-3-[[(2RS)-3-hydroxy-2-phenylpropanoyl]oxy]-8-methyl-8-(1-methylethyl)-8azoniabicyclo[3.2.1]octane

10 mg

EPY0001166

Irbesartan

60 mg

EPY0001156

Irbesartan impurity A 1-(pentylamino)-N-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]cyclopentanecarboxamide

10 mg

20 mg 120 mg

EPI0375000

Isoconazole

200 mg

EPI0380000

Isoconazole nitrate

200 mg

EPI0400000

Isoemetine hydrobromide

25 mg

EPY0000858

Isoflurane

1.5 mL

EPY0000037

Isoflurane - Reference Spectrum

unit

EPI0460000

Isoleucine

EPI0465000

Isomalt

EPY0000070

Isomaltooligosaccharide

0.9 mg

EPI0500000

Isoniazid

100 mg

EPI0599990

Isoprenaline hydrochloride

EPI0600000

Isoprenaline sulfate

500 mg

EPI0725000

Isopropyl hexadecanoate

100 mg

EPI0750000

Isopropyl tetradecanoate

EPI0775000

Isosorbide dinitrate

300 mg

EPI0775010

Isosorbide mononitrate

100 mg

EPI0775020

Isosorbide-2-nitrate

50 mg

EPI0800000

Isotretinoin

60 mg

Isotretinoin for peak identification

10 mg

Isoxsuprine hydrochloride

50 mg

New EPY0001218 EPI0900000 EPY0000366

Isradipine

EPY0000367

Isradipine impurity D methyl 1-methylethyl 4-(2,1,3-benzoxadiazol-4-yl)-2,6-dimethylpyridine-3,5-dicarboxylate

EPI7000000

Itraconazole

EPY0001100

Itraconazole for system suitability

EPI8000010

Ivermectin

EPY0000575

Ivy leaf standardised tincture

EPY0000041

Josamycin

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

50 mg 3000 mg

50 mg

2 mL

125 mg 5 mg 150 mg 15 mg 150 mg 2 mL 150 mg

279

European Pharmacopoeia Code

Product

EPY0000042

Josamycin propionate

Unit

EPY0001315

Josamycin for peak identification

25 mg

EPK0100000

Kanamycin B sulfate

20 mg

EPK0200000

Kanamycin monosulfate

EPY0000450

Ketamine hydrochloride Controlled Substance

10 mg

EPK0551000

Ketamine impurity A 1-[(2-chlorophenyl)(methylimino)methyl]cyclopentanol

50 mg

EPY0000246

Ketobemidone hydrochloride - Reference Spectrum

EPY0000244

Ketobemidone impurity B B 1-[4-(3-hydroxyphenyl)-1-methylpiperidin-4-yl]ethanone

5 mg

EPY0000245

Ketobemidone impurity C 1-[4-(3-hydroxyphenyl)piperidin-4-yl]propan-1-one

5 mg

EPK0600000

Ketoconazole

150 mg

150 mg

unit

150 mg

EPK1000000

3-Ketofusidic acid

10 mg

EPK2000000

Ketoprofen

50 mg

EPK2000010

Ketoprofen impurity A 1-(3-benzoylphenyl)ethanone

10 mg

EPK2000015

Ketoprofen impurity C 3-[(1RS)-1-carboxyethyl]benzoic acid

EPY0000486

Ketorolac trometamol

EPY0000626

Ketorolac trometamol for peak identification

EPY0000164

Ketotifen hydrogen fumarate - Reference Spectrum

EPY0000161

Ketotifen impurity G 4-(1-methylpiperidin-4-ylidene)-4H-benzo(4,5)cyclohepta(1,2-b)thiophen-9,10-dione

New EPY0001200

Kudzuvine root dry extract

5 mg 10 mg 5 mg unit 0.0225 mg 200 mg

EPL0050000

Labetalol hydrochloride

80 mg

EPL0129000

Lactitol monohydrate

EPY0000257

Lactobionic acid

100 mg

EPA1206000

Lactose (anhydrous)

100 mg

EPL0100000

Lactose

100 mg

EPL0130000

Lactulose

EPY0000188

Lactulose for system suitability

EPY0000425

Lamivudine

EPY0000518

Lamivudine for system suitability 1

10 mg

EPY0000426

Lamivudine for system suitability 2

10.3 mg

60 mg

3000 mg 12 mg 150 mg

EPY0001030

Lamotrigine

10 mg

EPY0001031

Lamotrigine for peak identification

20 mg

EPY0001085

Lamotrigine for system suitability

10 mg

EPY0001032

Lamotrigine impurity E 2,3-dichlorobenzoic acid

10 mg

EPY0000773

Lansoprazole

60 mg

EPY0000774

Lansoprazole for peak identification

New EPY0001474

Lauric acid

1 mg 1500 mg

EPY0000654

Leflunomide

EPY0000487

Leflunomide impurity A 4-(trifluoromethyl)aniline

100 mg

EPY0000674

Leflunomide for peak identification

EPY0000685

Letrozole

70 mg

EPL0375000

Leucine

50 mg

EPL0376000

Leuprorelin

EPL0376001

Leuprorelin - Reference Spectrum

EPY0000047

Levamisole hydrochloride for system suitability

60 mg

EPL0380000

Levamisole hydrochloride

50 mg

EPY0000048

Levamisole - Reference Spectrum

280

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

25 mg 1 mg

1 mg unit

unit

Edition 2012/2013

European Pharmacopoeia Code

Product

EPY0001253

Levetiracetam

Unit

EPY0001254

Levetiracetam impurity A (2RS)-2-(2-oxopyrrolidin-1-yl)butanoic acid

10 mg

EPY0001255

Levetiracetam impurity B (2Z)-2-(2-oxopyrrolidin-1-yl)but-2-enamide

10 mg

EPY0001256

Levetiracetam impurity C pyridin-2-ol

10 mg

EPY0001257

Levetiracetam impurity D (2R)-2-(2-oxopyrrolidin-1-yl)butanamide ((R)-etiracetam)

10 mg

EPL0390000

Levocabastine hydrochloride

EPL0390008

Levocabastine impurity D 1-[cis-4-cyano-4-(4-fluorophenyl)cyclohexyl]-

EPL0399900

Levocarnitine

EPL0399905

Levocarnitine impurity A (E)-or(Z)-4-(trimethylammonio)but-2-enoate

EPL0400000

Levodopa

EPL0420000

Levodropropizine

60 mg

EPL0420002

Levodropropizine impurity A (2R)-3-(4-phenylpiperazin-1-yl)propane-1,2-diol(dextrodropropizine)

20 mg

EPY0001033

Levodropropizine impurity B 1-phenylpiperazine

50 mg

EPY0001048

Levodropropizine impurity C 2,3-epoxypropan-1-ol

300 mg

EPL0500000

Levomepromazine hydrochloride

100 mg

EPL0505000

Levomepromazine maleate

50 mg

EPL0551000

Levonorgestrel

30 mg

New EPY0001379

Levonorgestrel impurity B 13-ethyl-17-hydroxy-18,19-dinor-17-alpha-pregn-5(10)-en-20-yn-3-one

10 mg

New EPY0001431

Levonorgestrel for system suitability

10 mg

New EPY0001382

Levothyroxine for peak identification

10 mg

110 mg

125 mg 20 mg

4-phenylpiperidine-4-carboxylic acid

EPL0570000

Levothyroxine sodium

EPL0595000

Lidocaine

EPL0600000 New EPY0001393

Lidocaine hydrochloride Lincomycin chlorhydrate for system suitability

125 mg 50 mg 100 mg

100 mg 50 mg 100 mg 10 mg

EPL0650000

Lincomycin hydrochloride

EPL0700000

Liothyronine sodium

EPY0000860

Liothyronine for peak identification

EPY0001235

Lisinopril for system suitability

EPL0702000

Lisinopril dihydrate

EPY0001234

Lisinopril impurity F (2S)-1-[(2S)-6-amino-2-[[(1S)-1-carboxy-3-cyclohexylpropyl]amino]hexanoyl]pyrrolidine2-carboxylic acid (cyclohexyl analogue)

0.01 mg

EPL0720000

Lithium clavulanate

125 mg

EPL0720800

Lithocholic acid

60 mg

EPY0000112

Lobeline hydrochloride

50 mg

EPL0745000

Lomustine

50 mg

EPL0750000

Loperamide hydrochloride

50 mg

EPY0000322

Loperamide hydrochloride for system suitability

15 mg

EPY0000341 New EPY0001505

250 mg 50 mg 0.0046 mg 2 mg 50 mg

Loperamide oxide monohydrate

20 mg

Lopinavir for system suitability

10 mg

EPY0000688

Loratadine

60 mg

EPY0000603

Loratadine for system suitability

20 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

281

European Pharmacopoeia Code

Product

EPY0000604

Loratadine impurity F ethyl 4-[(11RS)-8-chloro-11-fluoro-6,11-dihydro-5H-benzo[5,6]cyclohepta [1,2-b]pyridin-11-yl]piperidine-1-carboxylate

10 mg

Unit

EPY0000605

Loratadine impurity H ethyl 4-oxopiperidine-1-carboxylate

50 mg

EPL0750500

Lorazepam Controlled Substance

100 mg

EPY0000576

Lorazepam for system suitability Controlled Substance

0.8 mg

EPY0000718

Lorazepam impurity D (5RS)-7-chloro-5-(2-chlorophenyl)-4,5-dihydro-1H1,4-benzodiazepine-2,3-dione

10 mg

EPY0001062

Losartan potassium

50 mg

EPY0001072

Losartan impurity D 2-butyl-4-chloro-1H-imidazole-5-carbaldehyde

EPY0001076

Losartan for system suitability

EPL0790000

Lovastatin

EPY0001136

Lovastatine for peak identification

EPY0001284

Lufenuron

EPY0001261

Lufenuron for peak identification

EPY0001265

Lufenuron impurity G 2,5-dichloro-4-[[[(2,6-difluorophenyl)carbonyl]carbamoyl] amino]phenyl phenyl carbonate

6 mg 0.0015 mg 60 mg 20 mg 140 mg 0.4028 mg 15 mg

EPL0800000

Lynestrenol

50 mg

EPY0001034

Lynestrenol for peak identification

20 mg

EPY0000397

Lysine acetate

60 mg

EPL0900000

Lysine hydrochloride

50 mg

EPY0001369

Macrogol 30 dipolyhydroxystearate

EPY0000745

Macrogol 40 sorbitol heptaoleate

EPY0001157

Macrogol polyvinyl alcohol grafted polymer

EPM0088000

Magnesium aspartate dihydrate

60 mg

Magnolol

20 mg

EPM0120000

Malathion

250 mg

EPM0120005

Malathion impurity A diethyl(2RS)-2-[(methoxy)(methylsulfanyl)-S-phosphinothioyl] butane dioate

10 mg

EPM0120010

Malathion impurity B diethyl(2RS)-2-(dimethoxy-S-phosphinothioyl)-butanedioate

10 mg

New EPY0001289

100 mg 20 mg 400 mg

EPM0100000

Maleic acid

EPY0000143

Malic acid - Reference Spectrum

100 mg

EPM0160000

Maltitol

1200 mg

EPM0200000

Mannitol

1200 mg

EPM0206000

Maprotiline hydrochloride

EPM0206040

Maprotiline impurity D 3-(9,10-dihydro-9,10-ethanoanthracen-9-yl)-N-methylprop-2-en-1-amine

unit

100 mg 25 mg

EPY0000819

Marbofloxacin

10 mg

EPY0000820

Marbofloxacin for peak identification

20 mg

EPM0210000

Measles vaccine (live) BRP

EPM0215000

Mebendazole

20 mg

5 uc

EPY0000144

Mebendazole for system suitability

20 mg

EPY0000168

Mebendazole - Reference Spectrum

EPY0001086

Mebrofenin

120 mg

EPM0220000

Meclozine dihydrochloride

150 mg

EPY0001310

Meclozine impurity B 4-chlorobenzhydrol

15 mg

EPY0001311

Meclozine impurity H 1-(4-chlorobenzhydryl)piperazine

15 mg

282

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

unit

Edition 2012/2013

European Pharmacopoeia Code

Product

EPM0240000

Medronic acid

Unit

EPY0001107

Medronic acid impurity A Tris(1-methylethoxy)phosphane

60 µl

EPY0001106

Medronic acid impurity B Tetrakis(1-methylethyl)methhylenediphosphonate

40 µl

20 mg

EPM0250000

Medroxyprogesterone acetate

EPM0250010

Medroxyprogesterone acetate for performance test

100 mg 50 mg

EPY0000598

Medroxyprogesterone acetate for system suitability

10 mg

EPM0252600

Mefenamic acid

EPY0001081

Mefenamic acid impurity A 2,3-dimethylaniline

100 mg

EPM0253000

Mefloquine hydrochloride

100 mg

EPM0260100

Megestrol acetate - Reference Spectrum

50 mg

unit

New EPY0001524

Megestrol acetate for system suitability

50 mg

New EPY0001507

Megestrol acetate for peak identification

25 mg

Meglumine

10 mg

EPY0001080

Meloxicam

50 mg

EPY0001035

Meloxicam impurity A ethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide

5 mg

EPY0001036

Meloxicam impurity B 5-methylthiazol-2-amine

5 mg

EPY0001037

Meloxicam impurity C N-[(2Z)-3,5-dimethylthiazol-2(3H)-ylidene]-4-hydroxy-2-methyl-2H-1,2benzothiazine-3-carboxamide 1,1-dioxide

5 mg

EPY0001039

Meloxicam impurity D N-[(2Z)-3-ethyl-5-methylthiazol-2(3H)-ylidene]-4-hydroxy-2-methyl-2H-1,2benzothiazine-3-carboxamide 1,1-dioxide

5 mg

EPY0001209

New EPY0001513

Melphalan - Reference Spectrum

New EPY0001457

Melphalan for system suitability

New EPY0001158

Melphalan hydrochloride

100 mg

EPM0300000

Menadione

100 mg

EPM0350000

Menthol

150 mg

EPM0370000

Mepivacaine hydrochloride

100 mg

EPM0370020

Mepivacaine impurity B (RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide

EPM0400000

Meprobamate Controlled Substance

EPM0500000

Mepyramine maleate

EPY0000679

Mepyramine impurity A N-(4-methoxybenzyl)pyridin-2-amine

10 mg

EPY0000680

Mepyramine impurity C pyridin-2-amine

10 mg

EPY0001252

Meropenem trihydrate

110 mg

EPY0000297

Mesalazine

125 mg

EPY0001040

Mesityl oxid

100 mg

EPY0000337

Mesna - Reference Spectrum

EPY0000316

Mesna impurity C 2-(Acetylsulphanyl)ethanesulphonic acid

10 mg

EPY0000317

Mesna impurity D 2,2'-(disulphanediyl)bis(ethanesulphonic acid)

10 mg

EPY0000227

Meso-rich exametazime

0.5 mg

EPY0000097

Mesterolone

60 mg

EPY0000096

Mesterolone impurity A 17β-hydroxy-1alpha-methylandrost-4-en-3-one

30 mg

EPM0600000

Mestranol

EPY0000301

Metacresol - Reference Spectrum

EPM0600500

Metacycline hydrochloride

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

unit 10 mg

60 mg 100 mg 1000 mg

unit

100 mg unit 50 mg 283

European Pharmacopoeia Code

Product

EPM0600900

Metamizole sodium

EPM0600905

Metamizole impurity A 4-formylamino-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one

15 mg

Metamizole impurity E 4-N-Demethylanalgin

15 mg

New EPY0001481

Unit

100 mg

EPM0605000

Metformin hydrochloride

EPY0000770

Methacrylic acid-ethylacrylate copolymer (1:1) - type A

200 mg

50 mg

EPY0000323

Methacrylic acid-ethyl acrylate copolymer (1:1) - type B

200 mg

EPM0610000

Methacrylic acid-ethylacrylate copolymer (1:1) - Reference Spectrum

unit

EPM0610030

Methacrylic acid-ethyl acrylate copolymer (1:1), dispersion 30% - Reference Spectrum

unit

EPM0620000

Methacrylic acid-methylmethacrylate copolymer (1:1) - Reference Spectrum

unit

EPM0630000

Methacrylic acid-methylmethacrylate copolymer (1:2) - Reference Spectrum

unit

EPM0800000

Methadone hydrochloride - Reference Spectrum

unit

EPY0000428

Methanol - Reference Spectrum

unit

EPM0900000

Methaqualone - Reference Spectrum

EPY0000754

Methenamine

10 mg

EPM0950000

DL-Methionine

50 mg

EPM0960000

Methionine

50 mg

EPM1000000

Methotrexate

EPY0000602

Methotrexate for peak identification

20 mg

EPY0000663

Methotrexate impurity C (2S)-2-[[4-[[(2-amino-4-oxo-1,4-dihydropteridin-6yl)methyl]methylamino]benzoyl]amino]pentanedioic acid (N-methylfolic acid, methopteridine)

10 mg

EPM1000008

Methotrexate impurity D 4-[[(2-amino-4hydroxypteridin-6-yl)methyl]methyl-amino]benzoic acid

10 mg

EPY0000664

Methotrexate impurity E 4-[[(2,4-diaminopteridin-6-yl)methyl]methylamino]benzoic acid (4-amino-N10-methylpteroic acid, APA)

10 mg

EPM1300000

Methylatropine bromide

100 mg

EPM1400000

Methylatropine nitrate

100 mg

EPM1450000

Methylcarbidopa

EPM1470000

Methyl 2-(4-chlorophenoxy)-2-methylpropionate

0.5 mL

EPM1500000

Methyldopa

50 mg

EPY0001374

Racemic methyldopa

EPY0001083

Methyldopa for system suitability

EPM1550000

Methylene chloride

EPM1551000

2-(1-Methylethyl)pentanoic acid

EPM1556000

Methyl 12-hydroxystearate

EPY0000398

Methyl nicotinate

EPY0000776

Methylergometrine maleate

EPY0000777

Methylergometrine for system suitability

unit

100 mg

1 mg

5 mg 0.024 mg 2 mL 25 mg 100 mg 25 mg 10 mg 0.53 mg

EPM1625000

Methylnitrosoindoline

110 mg

EPM1650000

Methyl parahydroxybenzoate

150 mg

EPY0001017

Methylphenidate hydrochloride Controlled Substance

EPY0000910

Methylphenidate impurity mixture

0.04 mg

EPM1700000

Methylphenobarbital Controlled Substance

500 mg

EPM1750000

Methylprednisolone

150 mg

EPM1755000

Methylprednisolone acetate

100 mg

EPM1755200

Methylprednisolone hydrogen succinate

125 mg

EPM1755220

Methylprednisolone hydrogen succinate for performance test

New EPY0001376

2-Methylpyrazine

EPY0000190

N-Methylpyrrolidone - Reference Spectrum

284

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

40 mg

50 mg 100 mg unit

Edition 2012/2013

European Pharmacopoeia Code

Product

EPM1770180

Methyl ricinoleate

Unit

125 mg

EPY0000418

Methylrosanilinium chloride

40 mg

EPY0000407

Methylrosanilinium chloride for system suitability

10 mg

EPM1770200

Methyl stearate

100 mg

EPM1800000

Methyltestosterone

100 mg

EPY0000861

Methyltestosterone for system suitability

10 mg

EPM1800900

Methylthioninium chloride

50 mg

EPM1800902

Methylthioninium impurity A 3-(dimethylamino)-7-(methylamino)phenothiazin-5-ylium

20 mg

EPM1808000

Metixene hydrochloride

75 mg

EPM1824990

Metoclopramid

EPM1825000

Metoclopramide hydrochloride

100 mg 50 mg

EPM1824995

Metoclopramide impurity A 4-(acetylamino)-5-chloro-N-(2-diethylaminoethyl)-2-methoxy benzamide

25 mg

EPM1825010

Metoclopramide impurity E N,N-diethylethane-1,2-diamine

20 mg

EPY0000701

Metolazone

80 mg

EPY0000702

Metolazone for system suitability

10 mg

EPY0000171

Metoprolol succinate - Reference Spectrum

EPM1830000

Metoprolol tartrate

60 mg

unit

EPY0000145

Metoprolol impurity A (2RS)-1-(ethylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol

10 mg

EPM1845000

Metrifonate

EPM1850000

Metronidazole

50 mg

EPM1851000

Metronidazole benzoate

50 mg

EPY0000069

Metronidazole benzoate - Reference Spectrum

EPY0000087

Metronidazole impurity A 2-methyl-4-nitroimidazole

10 mg

EPM1860000

Mexiletine hydrochloride

100 mg

EPY0000202

Mexiletine impurity C 1,1'-[(3,3',5,5'-tetramethylbiphenyl-4,4'-diyl)bisoxy]dipropan-2-amine

2 mg

EPY0000203

Mexiletine impurity D (2RS)-2-(2,6-dimethylphenoxy)propan-1-amine

2 mg

100 mg

unit

EPM1875000

Mianserin hydrochloride

EPY0001041

Mianserin impurity B (14bRS)-2-methyl-1,2,3,4,10,14b-hexahydrodibenzo[c,f] pyrazino[1,2-a]azepine-8-sulfonic acid

EPY0000862

Mianserin hydrochloride for system suitability

EPM1880000

Miconazole

EPM1900000

Miconazole nitrate

EPM2200000

Midazolam Controlled Substance

EPY0000562

Midazolam impurity C acide 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo [1,5-a][1,4]benzodiazepine-3-carboxylique

EPY0000599

Midazolam for system suitability Controlled Substance

EPY0000539

Milk thistle standardised dry extract

120 mg

EPM2280000

Minocycline hydrochloride

125 mg

EPM2300000

100 mg 10 mg

1.01 mg 70 mg 100 mg 50 mg 0.08 mg

1 mg

Minoxidil

50 mg

Minoxidil for system suitability

10 mg

EPY0000705

Mirtazapine

10 mg

EPY0000721

Mirtazapine for system suitability

10 mg

EPY0000490

Misoprostol

60 mg

EPY0001162

Misoprostol for system suitability

EPY0000378

Mitomycin

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

New EPY0001432

5 mg 120 mg

285

European Pharmacopoeia Code

Product

EPM2305000

Mitoxantrone hydrochloride

EPM2305005

Mitoxantrone impurity A 1-amino-5,8-dihydroxy-4-[[2-[(2-hydroxyethyl)amino]ethyl]amino]anthracene-9,10-dione

Unit

50 mg 5 mg

EPY0000635

Modafinil

110 mg

EPY0000636

Modafinil for system suitability

0.1 mg

EPY0000251

Molgramostim

0.3 mL

EPY0000821

Molsidomine

EPY0000822

Molsidomine impurity B N-Nitrosomorpholine

10 mg

EPY0000823

Molsidomine impurity D morpholine-4-carbaldehyde

10 mg

EPM2900000

5 mg

Mometasone furoate

100 mg

New EPY0001436

Montelukast dicyclohexylamine

150 mg

New EPY0001435

Montelukast for peak identification

20 mg

New EPY0001433

Montelukast racemate

20 mg

New EPY0001434

Montelukast sodium

150 mg

EPY0000028

Morantel hydrogen tartrate

50 mg

EPY0000451

Morphine hydrochloride (trihydrate) Controlled Substance

25 mg

EPY0000452

Morphine sulphate Controlled Substance

40 mg

EPY0000830

Morphine for system suitability Controlled Substance

15 mg

EPY0000772

Moxidectin

70 mg

EPY0000747

Moxidectin for system suitability

EPY0000703

Moxifloxacin hydrochloride

EPY0000717

Moxifloxacin for peak identification

10 mg

EPY0000226

Moxonidine

50 mg

EPY0000222

Moxonidine impurity A 4,6-dichloro-N-(imidazolidin-2-ylidene)-2-methylpyrimidin-5-amine

10 mg

10 mg 110 mg

EPM3600000

Mumps vaccine (live) BRP

EPM3805000

Mupirocin - Reference Spectrum

EPM3805500

Mupirocin calcium - Reference Spectrum

EPM3806000

Mupirocin lithium

EPY0000489

Mycophenolate mofetil

30 mg

EPY0000519

Mycophenolate mofetil for peak identification

10 mg

EPY0000692

Mycoplasma fermentans BRP

1 mL

EPY0000690

Mycoplasma hyorhinis BRP

1 mL

EPY0000691

Mycoplasma orale BRP

1 mL

EPY0000689

Mycoplasma synoviae BRP

EPY0000485

Myo-inositol

New EPY0001484

Medroxyprogesterone acetate for peak identification

5x33 mg unit unit 100 mg

1 mL 1020 mg 25 mg

EPN0020000

Nabumetone

60 mg

EPN0020020

Nabumetone impurity D (E)-4-(6-methoxynaphthalen-2-yl)but-3-en-2-one

10 mg

EPN0020030

Nabumetone impurity F 6,6'-dimethoxy-2,2'-binaphthalenyl

10 mg

EPY0000146

Nadolol

100 mg

EPY0001215

Nadolol impurity mixture

0.01 mg

EPN0025000

Nadroparin calcium

250 mg

EPY0000077

Naftidrofuryl - Reference Spectrum

EPY0000120

Naftidrofuryl impurity A 2-[(naphtalen-1-yl)methyl]-3-(tetrahydrofuran-2-yl)propanoic acid

10 mg

EPY0000121

Naftidrofuryl impurity B ethyl 2-[(naphtalen-1-yl)methyl]-3-(tetrahydrofuran-2-yl)propanoate

25 mg

286

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

unit

Edition 2012/2013

European Pharmacopoeia Code

Product

EPY0000331

Naftidrofuryl impurity F 2-[(diethylamino)ethyl 2-[(naphthalen-2-yl)methyl]-3(tetrahydrofuran-2-yl)propanoate

Unit

EPN0050000

Nalidixic acid

100 mg

EPN0075000

Naloxone hydrochloride dihydrate

100 mg

EPY0000695

Naloxone for peak identification

10 mg

EPY0000400

Naltrexone hydrochloride

50 mg

EPY0000410

Naltrexone impurity C N-(3-butenyl)-noroxymorphone

15 mg

10 mg

EPY0000542

Nandrolone decanoate

EPY0000547

Nandrolone decanoate for peak identification

10 mg

5 mg

EPY0000548

Nandrolone decanoate for system suitability

10 mg

EPN0080000

Naphazoline hydrochloride

50 mg

EPN0100000

Naphazoline nitrate

10 mg

EPN0200000

Naphazoline impurity A N-(2-aminoethyl)-2-(naphthalen-1-yl)acetamide (Naphthylacetylethylenediamine)

10 mg

EPN0250000

Naproxen

EPY0000399

Naproxen (racemic)

10 mg

EPY0000631

Naproxen impurity L 1-(6-Methoxynaphthalen-2-yl)ethanone (Acetylnerolin)

10 mg

100 mg

New EPY0001378

Naringin

New EPY0001437

Nateglinide

20 mg

New EPY0001440

Nateglinide impurity A trans-4-(1-methylethyl)cyclohexanecarboxylic acid

10 mg

New EPY0001441

Nateglinide impurity B N-[[trans-4-(1-methylethyl)cyclohexyl]carbonyl]-Lphenylalanine (L-phenylalanine isomer)

15 mg

New EPY0001442

Nateglinide impurity C N-[[cis-4-(1-methylethyl)cyclohexyl]carbonyl]-D-phenylalanine (cis-isomer)

10 mg

EPN0300000

Neamine

0.5 mg

EPN0399000

Neohesperidin dihydrochalcone

125 mg

EPN0399004

Neohesperidin dihydrochalcone impurity B 7-[[2-O-(6-deoxy-α-L-mannopyranosyl)-ß-D-glucopyranosyl]oxy]-5-hydroxy-2(3-hydroxy-4-methoxyphenyl)-4H-1-benzopyran-4-one (neodiosmin)

200 mg

10 mg

EPN0400000

Neomycin sulfate

50 mg

EPN0401000

Neomycin sulphate for microbiological assay

25 mg

EPN0500000

Neostigmine bromide

50 mg

EPN0550000

Neostigmine metilsulfate

50 mg

EPN0559000

Netilmicin sulphate

EPY0000520

Nevirapine (anhydrous)

New EPY0001499

Nevirapine hemihydrate

2x25 mg 30 mg 15 mg

EPY0000521

Nevirapine for peak identification

0.058 mg

EPY0000388

Newcastle Disease Vaccine (inacativated) BRP

EPY0000287

Nicergoline - Reference Spectrum

EPY0001373

Nicergoline

EPY0001362

Nicergoline for peak identification

1 mg

EPY0001352

Nicergoline for system suitability

10 mg

EPY0000283

Nicergoline impurity A [(6aR,9R,10aS)-10a-methoxy-4,7-dimethyl4,6,6a,7,8,9,10,10a-octahydroindol [4,3-fg]quinolin-9-yl]methyl 5-chloropyridine-3-carboxylate

10 mg

EPY0001356

Nicergoline impurity D 5-bromopyridine-3-carboxylic acid

20 mg

EPN0560000

Niclosamide (anhydrous)

50 mg

EPN0600000

Nicotinamide

50 mg

EPN0590000

Nicotine - Reference Spectrum

unit

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

287

4 uc unit 50 mg

European Pharmacopoeia Code

Product

EPN0590200

Nicotine ditartrate

New EPY0001425 EPY0001023

Nicotine ditartrate dihydrate Nicotine for system suitability

Unit

120 mg 15 mg 1 mg

EPN0700000

Nicotinic acid

100 mg

EPY0001268

Nicotinic acid impurity mixture

0.12 mg

EPN0750000

Nifedipine

50 mg

EPN0750010

Nifedipine impurity A Dimethyl 2,6-dimethyl-4-(2-nitrophenyl) pyridine-3,5-dicarboxylate

20 mg

EPN0750015

Nifedipine impurity B Dimethyl 2,6-dimethyl-4-(2-nitrosophenyl) pyridine-3,5-dicarboxylate

20 mg

EPY0000824

Niflumic acid

10 mg

EPY0000825

Niflumic acid impurity A 2-chloropyridine-3-carboxylic acid

10 mg

EPY0000826

Niflumic acid impurity B 2-hydroxy-N-(3-(trifluoromethyl)phenyl)pyridine-3-carboxamide

10 mg

EPY0000827

Niflumic acid impurity E 6-((3-(trifluoromethyl)phenyl)amino)pyridine-3-carboxylic acid

15 mg

EPY0000836

Nifuroxazide

10 mg

EPN0800000

Nikethamide

1 mL

EPY0000829

Nilutamide

EPY0000894

Nilutamide impurity B 4-nitro-3-(trifluoromethyl)aniline

EPN0845000

Nimesulide

EPN0845008

Nimesulide impurity D 4-nitro-2-phenoxyaniline

EPY0001237

Nimesulide for peak identification

10 mg

EPN0850000

Nimodipine

50 mg

EPN0850010

Nimodipine impurity A 2-methoxyethyl 1-methylethyl 2,6-dimethyl-4-(3-nitrophenyl) pyridine-3,5-dicarboxylate

EPN0900000

Nitrazepam Controlled Substance

EPN0900010

Nitrazepam impurity A 3-amino-6-nitro-4-phenylquinol-2-one

25 mg

EPN0905000

Nitrendipine

60 mg

New EPY0001456

110 mg 5 mg 100 mg 0.004 mg

1 mL

100 mg

Nitrendipine for peak identification

10 mg

EPN0905005

Nitrendipine impurity A ethyl methyl-2,6-dimethyl-4-(3-nitrophenyl) pyridine-3,5-dicarboxylate; (nitrophenylpyridine analogue)

30 mg

EPN0930000

Nitric oxide - Reference Spectrum

EPN0950000

Nitrofural

100 mg

EPY0001377

Nitrofural for peak identification

0.11 mg

EPN1000000

Nitrosotriaminopyrimidine

EPN1090000 New EPY0001278

Nizatidine

unit

50 mg 250 mg

Nizatidine for system suitability

10 mg

EPN1090060

Nizatidine impurity F (EZ)N1,N1-[thiazole-2,4-diylbis(methylenesulphanediylethylene)] bis(N’-methyl-2-nitroethene-1,1-diamine)

10 mg

EPN1080000

Nomegestrol acetate

EPN1080005

Nomegestrol acetate impurity A 6-alpha-methyl-3,20-dioxo-19-norpregn-4-en-17-yl acetate

EPY0001314

1-nonadecanol

EPY0000670

Nonivamide

10 mg

EPY0000755

Nonoxinol 9

10 mg

EPN1100000

Noradrenaline tartrate

288

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg 50 mg 400 mg

200 mg

Edition 2012/2013

European Pharmacopoeia Code

Product

EPY0000681

Noradrenaline impurity D 4[(1R)-2-amino-1-methoxyethyl]benzene-1,2-diol (Noradrenaline methyl ether)

15 mg

Unit

EPY0000682

Noradrenaline impurity E 2-chloro-1-(3,4-dihydroxyphenyl)ethanone

10 mg

EPY0000686

Noradrenaline impurity F N-benzyl-1-phenylmethanamine

10 mg

EPN1130000

Norcyclobenzaprine

25 mg

EPN1140000

Nordazepam Controlled Substance Dipotassium clorazepate impurity B

50 mg

EPN1200000

Norethisterone

100 mg

EPN1225000

Norethisterone acetate

100 mg

EPY0000522

Norethistherone for system suitability

10 mg

EPN1230000

Norfloxacin

50 mg

EPY0001301

Norfloxacin for peak identification

10 mg

EPN1230010

Norfloxacin impurity A 7-chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid

20 mg

EPY0001015

Norfloxacin for system suitability

EPY0000724

Norgestimate

EPY0000725

Norgestimate for system suitability

EPN1250000

Norgestrel

30 mg

EPN1279000

Norpseudoephedrine hydrochloride Controlled Substance

50 mg

EPY0001296

Nortriptyline for system suitability

20 mg

EPN1280000

Nortriptyline hydrochloride

10 mg

8 mg 10 mg 5 mg

EPN1300000

Noscapine

100 mg

EPN1400000

Nystatin

100 mg

EPO0100900

Octoxinol 10

300 mg

EPY0000368

Octyl gallate

30 mg

EPO0101000

Octyldodecanol

400 mg

EPO0120000

Ofloxacin

50 mg

EPO0120010

Ofloxacin impurity A (RS)-9,10-difluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido [1,2,3-de][1,4]benzoxazine-6-carboxylic acid (FPA)

20 mg

EPO0120050

Ofloxacin impurity E (RS)-9-fluoro-3-methyl-10-(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido [1,2,3-de] [1,4]benzoxazine-6-carboxylic acid

20 mg

New EPY0001370

Olanzapine

New EPY0001380

Olanzapine for system sitability

New EPY0001392

Olanzapine impurity A 5-methyl-2-[(2-nitrophenyl)amino]thiophene-3-carbonitrile

New EPY0001479

Oleic acid

EPY0000805

Oleuropein

New EPY0001405

Olmesartan medoxomil

New EPY0001424

200 mg 10 mg 5 mg 2000 mg 20 mg 100 mg

Olmesartan medoxomil for system suitability

10 mg

EPO0146000

Olsalazine sodium

60 mg

EPO0146010

Olsalazine sodium for performance test

60 mg

EPO0150000

Omeprazole

50 mg

EPY0001043

Omeprazole magnesium

10 mg

EPY0001042

Omeprazole for peak identification

10 mg

EPO0151000

Omeprazole impurity D Omeprazole sulphone

10 mg

EPY0000218

Ondansetron hydrochloride dihydrate

200 mg

EPY0000197

Ondansetron for LC system suitability

10 mg

EPY0000196

Ondansetron for TLC system suitability

30 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

289

European Pharmacopoeia Code

Product

EPY0001345

Ondansetron impurity A (3RS)-3-[(dimethylamino)methyl]-9-methyl-1,2,3,9tetrahydro-4H-carbazol-4-one

10 mg

Unit

EPY0000195

Ondansetron impurity D 9-methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-one

10 mg

EPY0001326

Ondansetron impurity E Imidazole

10 mg

EPY0001320

Ondansetron impurity F

10 mg

EPY0001346

Ondansetron impurity G (3RS)-3-[(1H-imidazol-1-yl)methyl]-9-methyl-1,2,3,9-tetrahydro4H-carbazol-4-one (C-demethylondansetron)

10 mg

EPY0001125

Orbifloxacin

EPY0001147

Orbifloxacin impurity mixture

EPO0180000

Orciprenaline sulfate

EPY0000895

Orciprenaline for system suitability

EPY0000101

Orphenadrine citrate

100 mg

EPY0000100

Orphenadrine hydrochloride

100 mg

EPY0001181

Orphenadrine for peak identification

0.42 mg

EPY0000102

Orphenadrine impurity E (RS)-N,N-dimethyl-2-[(3-methylphenyl)phenylmethoxy]ethanamine (meta-methylbenzyl isomer)

EPY0001337

Oseltamivir phosphate impurity B free

EPY0001338

Oseltamivir impurity A (3R,4R,5S)-5-acetamido-4-amino-3-(1-ethylpropoxy)cyclohex-1-ene-1-carboxylic acid

10 mg

EPY0001339

Oseltamivir impurity B ethyl (1R,2R,3S,4R,5S)-4-acetamido-5-amino-2-azido-3(1-ethylpropoxy)cyclohexanecarboxylate

10 mg

EPY0001340

Oseltamivir impurity C (3R,4R,5S)-4-acetamido-5-amino-3-(1-ethylpropoxy)cyclohex-1-ene-1-carboxylic acid

10 mg

EPY0001341

Oseltamivir impurity H tributylphosphane oxide

30 mg

EPY0001207

Osthole

20 mg

EPO0200000

Ouabain

150 mg

EPY0000638

Oxacillin sodium monohydrate

110 mg

EPY0000560

Oxacillin for peak identification

EPY0000271

Oxaliplatin

EPY0000273

Oxaliplatin impurity C (OC-6-33)-[(1R,2R)-cyclohexane-1,2-diamine-kN,kN'][ethanedioato(2-)kO¹,kO²]dihydroxyplatinum

25 mg

EPY0000274

Oxaliplatin impurity D (SP-4-2)-[(1S,2S)-cyclohexane-1,2-diamine-kN,kN'][ethanedioato(2-)kO¹,kO² ]platinum (S,S-enantiomer of oxaliplatin)

10 mg

EPO0225000

Oxazepam Controlled Substance

50 mg

EPY0000543

Oxazepam for peak identification

EPY0000350

Oxeladin hydrogen citrate

50 mg

EPY0000404

Oxeladin impurity C 2-(diethylamino)ethyl 2-ethyl-2-phenylbutanoate

10 mg

EPY0000390

Oxeladin impurity D 2-(2-diethylaminoethoxy)ethyl 2-phenyl-butyrate dihydrogen citrate

20 mg

EPO0225800

Oxfendazole for veterinary use

50 mg

EPY0000224

Oxfendazole impurity B methyl[5-(phenylsulphonyl)-1H-benzimidazole-2-yl]carbamate

10 mg

EPY0000225

Oxfendazole with impurity D

10 mg

EPY0000709

50 mg

EPY0000715

Oxitropium bromide Oxitropium bromide impurity B (1R,2R,4S,5S,7s)-7-[[(2S)-3-hydroxy-2-phenylpropanoyl)oxy]-9,9-dimethyl-3-oxa-9azoniatricyclo[3.3.1.02,4]nonane (methylhyoscine)

290

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

200 mg 0.0008 mg 100 mg 5 mg

30 mg

300 mg

10 mg 250 mg

0.008 mg

15 mg

Edition 2012/2013

European Pharmacopoeia Code

Product

EPY0000713

Oxitropium bromide impurity D (1R,2R,4S,5S,7s,9r)-9-ethyl-9-methyl-7-[(2-phenylprop-2-enoyl)oxy]-3-oxa-9azoniatricyclo[3.3.1.02,4]nonane (apo-N-ethylhyoscine)

10 mg

Unit

EPO0240000

Oxolinic acid

50 mg

EPO0240005

Oxolinic acid impurity A 8-hydroxy-1,3-dioxolo[4,5-g]quinoline-7-carboxylic acid

20 mg

EPO0240010

Oxolinic acid impurity B ethyl 5-ethyl-8-oxo-5,8-dihydro-1,3-dioxolo[4,5-g]quinoline-7-carboxylate

20 mg

EPO0250000

Oxprenolol hydrochloride

50 mg

EPO0260000

Oxibendazole

100 mg

EPO0270000

Oxybuprocaine hydrochloride

150 mg

EPO0288000

Oxybutynin hydrochloride

150 mg

EPO0288005

Oxybutynin impurity A 4-(diethylamino)but-2-ynyl(RS)-2-(cyclohex-3-enyl)-2-cyclohexyl-2-hydroxyacetate

EPY0000492

Oxycodone hydrochloride Controlled Substance

EPY0000453

Oxycodone impurity D 7,8-didehydro-4,5 alpha-epoxy-14-hydroxy-3-methoxy-17methylmorphinan-6-one (14-hydroxycodeinone)

50 mg

EPO0290000

Oxymetazoline hydrochloride

80 mg

EPY0001044

Oxymetazoline impurity A N-(2-aminoethyl)-2-[4-(1,1-dimethylethyl)-3-hydroxy-2,6-dimethylphenyl]acetamide

10 mg

EPO0400000

Oxytetracycline

EPO0500000

Oxytetracycline hydrochloride

10 mg 100 mg

100 mg 20 mg

EPO0700000

Oxytocin

EPO0770000

Oxytocin/Desmopressin validation mixture about 0.1 mg oxytocin + 0.1 mg desmopressin per vial

0.2 mg

EPY0000698

Paclitaxel

40 mg

EPY0000699

Paclitaxel impurity C N-debenzoyl-N-hexanoylpaclitaxel

EPY0000700

Paclitaxel natural for peak identification

10 mg

EPY0000719

Paclitaxel semi-synthetic for peak identification

10 mg

EPY0000739

Paclitaxel semi-synthetic for system suitability

1 mg

EPP0090000

Palmitic acid

EPY0000524

Pamidronate disodium pentahydrate

1 mg

5 mg

100 mg 10 mg

EPP0100000

Pancrease powder (amylse and lipase) BRP

2000 mg

EPP0200000

Pancreas powder (protease) BRP

2000 mg

EPP0250000

Pancuronium bromide Vecuronium impurity B

20 mg

EPY0000577

Pancuronium bromide for system suitability

20 mg

EPY0000835

Pantoprazole sodium sesquihydrate

20 mg

EPY0001001

Pantoprazole for system suitability

EPP0270000

Papaverine hydrochloride

25 mg

EPP0300000

Paracetamol

50 mg

EPY0000780

Paraffin (hard)

10 mg

EPY0000058

Paraffin (liquid) - Reference Spectrum

EPY0000913

Paraffin (White soft)

10 mg

EPY0000912

Paraffin (Yellow soft)

10 mg

0.5055 mg

unit

EPP0305000

Parnaparin sodium

250 mg

EPY0000578

Paroxetine hydrochloride (anhydrous)

100 mg

EPY0000281

Paroxetine hydrochloride hemihydrate

200 mg

EPY0000233

Paroxetine impurity A (3S,4R)-3-[[1,3-benzodioxol-5-yloxy]methyl]-4-phenylpiperidine (desfluoroparoxetine)

15 mg

EPY0000579

Paroxetine hydrochloride (anhydrous) impurity C (3S,4R)-3-[(1,3-benzodioxol-5-yloxy)methyl]-1-benzyl-4-(4-fluorophenyl)piperidine (N-benzylparoxetine)

10 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

291

European Pharmacopoeia Code

Product

EPY0000256

Paroxetine impurity D (3R,4S)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine ((+)-transparoxetine)

5 mg

EPY0000580

Paroxetine impurity E (3RS,4RS)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4fluorophenyl)piperidine (cis-paroxetine)

5 mg

EPY0000581

Paroxetine hydrochloride (anhydrous) impurity H [(3S,4R)-1-benzyl-4-(4-fluorophenyl)piperidin-3-yl]methanol

EPY0000630

Paroxetine for system suitability

EPP0309000

Pefloxacin mesilate dihydrate

EPP0309020

Pefloxacin impurity B 1-ethyl-6-chloro-7-(4-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (chlorinated homologue of pefloxacin)

EPP0309030

Pefloxacin impurity C 1-ethyl-6-fluoro-5-(4-methylpiperazin-1yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (isopefloxacin)

0.01 mg

EPP0307000

Penbutolol sulfate

100 mg

EPP0307005

Penbutolol impurity A (2S)-1-[2-(cyclopent-1-enyl)phenoxy]-3-[(1,1-dimethylethyl)amino]propan-2-ol

EPP0310000

Penicillamine

100 mg

EPP0320000

Penicillamine disulphide 3,3-(disulphanediyl)bis[(2)-2-amino-3-methylbutanoic]acid

100 mg

EPP0405000

Pentamidine diisetionate

EPP0405500

Pentazocine - Reference Spectrum

unit

EPP0405510

Pentazocine hydrochloride - Reference Spectrum

unit

EPY0000417

Pentazocine lactate - Reference Spectrum

unit

EPY0001051

Pentetate sodium calcium

100 mg

EPP0500000

Pentobarbital Controlled Substance

500 mg

EPP0510000

Pentoxifylline

100 mg

EPY0000076

Pentoxyverine hydrogen citrate - Reference Spectrum

EPY0000098

Pentoxyverine impurity A 1-phenylcyclopentanecarboxylic acid

10 mg

EPY0000099

Pentoxyverine impurity B 2-(diethylamino)ethyl-1-phenylcyclopentanecarboxylate (caramiphen)

10 mg

EPP0525000

Pepsin powder

EPY0000010

Pergolide mesilate

EPY0000237

Perindopril impurity A (2S,3aS,7aS)-octahydro-1Hindole-2-carboxylic acid

10 mg

EPY0000207

Perindopril for stereochemical purity

40 mg

EPY0000238

Perindopril tert-butylamine

40 mg

EPY0000771

Perindopril for peak identification

EPP0550000

Perphenazine

EPY0001045

Perphenazine for system suitability

Unit

10 mg 5 mg 200 mg 10 mg

20 mg

30 mg

unit

2000 mg 150 mg

5 mg 100 mg 5 mg

EPY0000021

Pertussis toxin BRP

EPP0600000 EPP0600002

Pethidine hydrochloride - Reference Spectrum Pethidine impurity A 1-methyl-4-phenylpiperidine (MPP)

20 mg

EPP0800000

Phenazone

20 mg

EPY0001138

Phenazone impurity A 5-methyl-2-phenyl-2,4-dihydro-3-pyrazol-3-one

20 mg

Pheniramine impurity A 2-Benzylpyridine

20 mg

New EPY0001428

2x0.05 mg unit

EPP0850000

Pheniramine maleate

250 mg

EPP0900000

Phenobarbital Controlled Substance

200 mg

EPY0001350

Phenobarbital impurity A (5RS)-5-ethyl-2,6-diimino-5-phenyltetrahydropyrimidin-4(1H)-one

15 mg

EPY0001351

Phenobarbital impurity B (5RS)-5-ethyl-6-imino-5-phenyldihydropyrimidine-2,4(1H,3H)-dione

15 mg

292

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia Code

Product

EPP0950000

Phenoxyethanol

Unit

2 mL

EPP1000000

Phenoxymethylpenicillin

250 mg

EPP1100000

Phenoxymethylpenicillin potassium

250 mg

EPP1109000

Phentolamine mesilate - Reference Spectrum

EPY0001127

Phentolamine mesilate

10 mg

EPY0001251

Phentolamine mesilate for system suitability

10 mg

unit

EPP1150000

Phenylalanine

EPP1200000

Phenylbutazone

EPY0000147

Phenylbutazone impurity B (4-butyl-4-hydroxy-1,2-diphenyl-3,5)pyrazolidinedione

20 mg

EPP1240000

Phenylephrine

60 mg

EPP1250000

Phenylephrine hydrochloride

50 mg

EPY0000683

Phenylephrine hydrochloride for peak identification

EPY0000229

Phenylmercuric acetate - Reference Spectrum

EPP1255100

Phenylmercuric borate - Reference Spectrum

60 mg 100 mg

2 mg unit unit

EPP1260000

50 mg

Phenylpropanolamine hydrochloride (Norephedrin hydrochloride) Drug Precursor

EPP1290000

Phenytoin

EPY0001167

Phenytoin for system suitability

EPP1300000

Phenytoin sodium

250 mg

EPY0000493

Phloroglucinol (anhydrous)

210 mg

EPY0000761

Pholcodine Controlled Substance

10 mg

EPY0000798

Pholcodine for peak identification Controlled Substance Phthalic acid benzene-1,2-dicarboxylic acid

10 mg

EPY0000766 EPP1500000

Phthalylsulfathiazole

100 mg

EPP1600000

Physostigmine salicylate

100 mg

EPP1605000

Physostigmine sulfate

100 mg

EPP1609000

Phytomenadione

150 mg

EPP1609010

trans-Epoxyphytomenadione

EPP1645000

Picotamide monohydrate

EPP1645005

Picotamide impurity A 4-methoxybenzene-1,3-dicarboxylic acid

25 mg

EPY0000124

Pidolate impurity B (2S)-2-[[[(2S)-5-oxopyrrolidin-2-yl]carbonyl]amino]pentanedioic acid

60 mg

EPY0000123

Pidolic acid

100 mg 20 mg

20 mg

10 mg 125 mg

125 mg

EPP1650000

Pilocarpine hydrochloride

50 mg

EPP1700000

Pilocarpine nitrate

50 mg

EPY0000106

Pilocarpine nitrate for system suitability

20 mg

EPY0000525

Pimobendan

10 mg

EPY0000401

Pimobendan for system suitability

0.1 mg

EPP1750000

Pimozide

150 mg

EPP1800000

Pindolol

100 mg

New EPY0001519

Pioglitazone for system suitability

New EPY0001520

Pioglitazone hydrochloride

New EPY0001476 EPY0000061

Pipemidic acid trihydrate Pipemidic acid trihydrate - Reference Spectrum

15 mg 120 mg 15 mg unit

EPP1890000

Piperacillin

100 mg

EPP1900000

Piperazine adipate

250 mg

EPP2000000

Piperazine citrate

250 mg

EPP2100000

Piperazine hydrate

250 mg

EPY0000288

Piracetam

120 mg

EPY0000038

Pirenzepine dihydrochloride monohydrate

250 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

293

European Pharmacopoeia Code

Product

EPP2120000

Piretanide

New EPY0001458

Unit

100 mg

Piretanide for system suitability

10 mg

EPP2120002

Piretanide impurity A 4-phenoxy-3(1H-pyrrol-1-yl)-5-sulphamoylbenzoic acid

20 mg

EPP2130000

Piroxicam

100 mg

EPP2150000

Pivampicillin

EPP2152000

Pivmecillinam hydrochloride

50 mg

EPP2152015

Pivmecillinam impurity C methylene 2,2-dimethylpropanoate (2RS,4S)-2-[[[(hexahydo-1H-azepin-1-yl) methylene]amino]methyl]-5,5-dimethylthiazolidin-4-carboxylate

EPP2155001

Plastic additive 01 (2RS)-2-ethylhexyl)benzene-1,2-dicarboxylate

EPP2155003

Plastic additive 03 N,N'-ethylenedialcanamide

100 mg

EPE0800000

Plastic additive 04 Epoxidised soya oil

500 mg

EPP2155005

Plastic additive 05 Epoxidised linseed oil

500 mg

EPP2155008

Plastic additive 08 Ethylene bis [3,3-bis[3-(1,1-dimethylethyl)-4-hydroxyphenyl]butanoate]

500 mg

EPP2155009

Plastic additive 09 pentaerythrityl tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]

250 mg

EPP2155010

Plastic additive 10 4,4',4''-(2,4,6-trimethylbenzene-1,3,5-triyltrismethylene)-trio[2,6-bis(1,1-dimethylethyl)phenol]

250 mg

EPP2155011

Plastic additive 11 Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate

500 mg

EPP2155012

Plastic additive 12 Tris(2,4-di-1,1-dimethylethylphenyl)phosphite R

250 mg

EPP2155013

Plastic additive 13 1,3,5-tris(3,5-di-1,1-dimethylethyl-4-hydroxybenzyl)-1H,3H,5H-1,3,5-triazine-2,4,6-trione

250 mg

EPP2155014

Plastic additive 14 2,2'-Di(octadecycloxy)5,5'-spirobi(1,3,2,-dioxaphosphorinane) R

250 mg

EPP2155015

Plastic additive 15 Dioctadecyl disulphide

500 mg

EPP2155016

Plastic additive 16 Didodecyl 3,3'-thiodipropionate R

250 mg

EPP2155017

Plastic additive 17 Dioctadecyl 3,3'-thiodipropionate R

250 mg

EPP2155018

Plastic additive 18

100 mg

EPO0140000

Plastic additive 20 Oleamide R

100 mg

EPE1260000

Plastic additive 21 Erucamide R

100 mg

EPP2155022

Plastic additive 22 Copolymer of dimethyl butanedioate and 1-(2-hydroxyethyl)-2,2,6,6-tetramethylpiperidin-4-ol Synonyms: copolymer of dimethyl succinate and (4-hydroxy-2,2,6,6-tetramethylpiperidin-1yl)ethanol

100 mg

EPP2155023

Plastic additive 23 di(isooctyl)2,2'-[(dioctylstannylene)bis(thio)]diacetate containing about 27% of (tri(isooctyl)2,2',2''-[monooctylstannylidyne)tris(thio)]triacetate Tin-content of 15.4%

200 mg

EPP2160000

Poliomyelitis vaccine (inactivated) BRP

EPP2161000

Poliomyelitis vaccine (oral) BRP

EPP2163920

Poloxamer 124

30 mg

EPP2164009

Poloxamer 188

100 mg

EPP2164020

Poloxamer 237

100 mg

EPP2164021

Poloxamer 338

100 mg

EPP2164030

Poloxamer 407

100 mg

EPP2170000

Polyacrylate - Reference Spectrum

EPP2400000

Polymyxin B sulfate

294

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg 10 mg

2 mL

5x0.5 mL 5x1 mL

unit 25 mg Edition 2012/2013

European Pharmacopoeia Code

Product

EPY0000355

Polymyxin B sulfate for microbiological assay

EPY0000289

Polysorbate 20 - Reference Spectrum

unit

EPY0000290

Polysorbate 40 - Reference Spectrum

unit

EPY0000291

Polysorbate 60 - Reference Spectrum

unit

EPY0000007

Polysorbate 80 - Reference Spectrum

unit

EPY0000792

Poly(vinyl acetate) dispersion 30%

EPP2600000

Poly(vinyl chloride)

EPP2649610

Potassium clavulanate - Reference Spectrum

Unit

25 mg

1500 mg 100 mg unit

EPY0001168

Potassium clavulanate impurity G

EPY0000315

Potassium hydrogen aspartate hemihydrate

5 mg

EPP2650000

Potassium sorbate

100 mg

EPY0001275

Potassium sucrose octasulfate

100 mg

EPP2660000

Povidone

50 mg

EPY0000466

Povidone (iodinated)

10 mg

EPY0001266

Pramipexole dihydrochloride monohydrate

EPY0001187

Pramipexole for system suitability

EPY0001267

Pramipexole impurity D (6R)-6-N-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine

EPY0000215

Pravastatin sodium - Reference Spectrum

EPY0000223

Pravastatin impurity A (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6R,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)2-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoic acid (6'-epipravastatin)

0.1 mg

EPY0000204

Pravastatin 1,1,3,3-tetramethylbutylamine

30 mg

EPP2669000

Prazepam Controlled Substance

50 mg

50 mg

5 mg 15 mg 5 mg unit

EPP2670000

Praziquantel

EPP2675000

Praziquantel impurity A (11bRS)-2-benzoyl-1,2,3,6,7,11b-hexahydro-4H-pyrazino[2,1-a]isoquinolin-4-one

10 mg

EPP2680000

Prazosin hydrochloride

50 mg

EPP2698000 New EPY0001443 EPP2698060

Prednicarbate

150 mg

100 mg

Prednicarbate for system suitability

10 mg

Prednicarbate impurity F 1,2-dihydroprednicarbate

10 mg

EPP2700000

Prednisolone

EPY0001359

Prednisolone for peak identification

150 mg 10 mg

EPY0001355

Prednisolone for system suitability

10 mg

EPP2800000

Prednisolone acetate

EPY0000582

Prednisolone acetate for peak identification

EPP2804000

Prednisolone hexanoate

EPP2805000

Prednisolone pivalate

100 mg

EPP2810000

Prednisolone sodium phosphate

100 mg

EPP2900000

Prednisone

100 mg

EPP2920000

Pregnenolone isobutyrate

150 mg

EPY0000263

Prekallikrein activator in albumin BRP

3x1 mL

EPP2939000

Prilocaine

150 mg

EPP2939060

Prilocaine hydrochloride

100 mg

New EPY0001408

120 mg 10 mg 10 mg

Prilocaine impurity B 2-methylbenzenamine hydrochloride

80 mg

EPP2939025

Prilocaine impurity E (RS)-N-(methylphenyl)-2-(propylamino)propanamide

25 mg

EPP2940000

Primaquine diphosphate

500 mg

EPP2950000

Primidone

150 mg

EPY0000369

Primidone for peak identification

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

5 mg

295

European Pharmacopoeia Code

Product

EPP3000000

Probenecid

100 mg

Unit

EPP3050000

Procainamide hydrochloride

100 mg

EPP3090000

Procaine benzylpenicillin

250 mg

EPP3100000

Procaine hydrochloride

100 mg

EPP3200000

Prochlorperazine maleate

100 mg

EPP3300000

Progesterone

50 mg

EPY0000148

Progesterone impurity C (20R)-20-hydroxypregn-4-en-3-one

10 mg

EPY0000179

Proguanil hydrochloride - Reference Spectrum

EPY0000181

Proguanil impurity C 1,5-bis(4-chlorophenyl)biguanide

10 mg

EPY0000182

Proguanil impurity D 1,5-bis(1-methylethyl)biguanide

10 mg

unit

EPP3350000

Proline

EPP3390000

Promazine hydrochloride

60 mg

EPP3400000

Promethazine hydrochloride

50 mg

EPY0000769

Promethazine impurity D (2RS)-N,N-dimethyl-1-(10H-phenothiazin-10-yl)propan-2-amine S-oxide

10 mg

EPY0000797

Promethazine for peak identification

10 mg

EPP3490000

Propacetamol hydrochloride - Reference Spectrum

100 mg

unit

EPY0000455

Propafenone hydrochloride

10 mg

EPY0000456

Propafenone impurity B 2E)-1-[2-[(2RS)-2-hydroxy-3-(propylamino)propoxy] phenyl]-3-phenylprop-2-en-1-one

10 mg

EPY0000278

Propanol - Reference Spectrum

EPY0000016

Propofol

290 mg

EPY0000017

Propofol for peak identification

0.1 mL

EPY0000018

Propofol impurity J 2,6-bis (1-methylethyl)-1,4-benzoquinone

20 mg

EPP3500000

Propranolol hydrochloride

30 mg

EPP3600000

Propranolol hydrochloride for performance test

EPY0000318

Propylene glycol dilaurate

100 mg

EPY0000319

Propylene glycol monolaurate

100 mg

unit

20 mg

EPP3640000

Propyl gallate

EPP3650000

Propyl parahydroxybenzoate

150 mg

50 mg

EPP3700000

Propylthiouracil

100 mg

EPP3750000

Propyphenazone

200 mg

EPP3760000

Protirelin

EPP3760020

D-His Protirelin

0.1 mg

EPP3800000

Proxyphylline

100 mg

2x5.03 mg

EPP3850000

Pseudoephedrine hydrochloride Drug Precursor

EPY0000387

Pseudoisoeugenyl 2-methylbutyrate for peak identification

EPP3900000

Purpureaglycoside A

25 mg

EPP4000000

Purpureaglycoside B

25 mg

EPY0000402

Pyrantel embonate

10 mg

EPY0000403

Pyrantel impurity A 1-methyl-2-[(Z)-2-(thiophen-2-yl)ethenyl]-1,4,5,6-tetrahydropyrimidine

20 mg

EPP4050000

Pyrazinamide

30 mg

EPP4099900

Pyridostigmine bromide

50 mg

EPP4099910

Pyridostigmine impurity A pyridin-3-yl-dimethylcarbamate

20 mg

Pyridostigmine bromide impurity B 3-hydroxy-1-methylpyridinium

10 mg

New EPY0001486 EPP4100000

Pyridoxine hydrochloride

296

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

50 mg 100 mg

100 mg

Edition 2012/2013

European Pharmacopoeia Code

Product

EPY0001226

Pyridoxine impurity A 6-methyl-1,3-dihydrofuro[3,4-c]pyridin-7-ol

EPP4200000

Pyrimethamine

Unit

5 mg 250 mg

EPY0000659

Pyrrolidone

20 mg

EPY0001009

Quercetin dihydrate

20 mg

EPQ0100000

Quinidine sulfate

300 mg

EPQ0200000

Quinine sulfate

300 mg

EPR0100000

Rabies vaccine (inactivated) for veterinary use BRP

EPY0000896

Racecadotril

EPY0000897

Racecadotril impurity A Ethanethioic acid

EPY0000898

Racecadotril impurity G benzyl[[(2RS)-2-benzyl-3-sulfanylpropanoyl]amino]acetate

EPY0000902

Racecadotril for peak identification

EPY0001134

Raloxifene hydrochloride

EPY0001135

Raloxifene hydrochloride for peak identification

3x86 mg 110 mg 1 mL 10 mg 5 mg 110 mg 10 mg

EPR0145000

Ramipril

20 mg

EPR0145005

Ramipril impurity A (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-(methoxycarbonyl)-3-phenylpropyl]amino] propanoly]octahydrocyclopenta[b]pyrrole-2-carboxylic acid (ramipril methylester)

10 mg

EPR0145010

Ramipril impurity B (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-[(methylethoxy)carbonyl]-3-phenylpropyl] amino] propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid (ramipril isopropyl ester)

10 mg

EPR0145015

Ramipril impurity C (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-(ethoxycarbonyl)-3-cyclohexylpropyl]amino] propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid (hexahydroramipril)

10 mg

EPR0145020

Ramipril impurity D ethyl(2S)-2-[(3S,5aS,8aS,9aS)-3-methyl-1,4-dioxodecahydro -1H-cyclopenta[e]pyrrolo[1,2a]pyrazin-2-yl]-4-phenylbutanoate (ramipril diketopiperazine)

10 mg

EPR0150000

Ranitidine hydrochloride

EPY0000416

Ranitidine impurity J 1,1'-N-[methylenebis(sulphanediylethylene)]bis (N'-methyl-2-nitroethene-1,1-diamine)

EPY0000411

Ranitidine for system suitability

20 mg

EPY0000457

Repaglinide

20 mg

EPY0000458

Repaglinide for system suitability

EPY0000459

Repaglinide impurity E 2-ethoxy-4-[2-[[(1R)-3-methyl-1-[2-(piperidin-1-yl)phenyl]butyl]amino]2-oxoethyl]benzoic acid

100 mg 0.00025 mg

6 mg 10 mg

EPR0200000

Reserpine

100 mg

EPR0250000

Residual solvents solution class I

1.4 mL

EPY0000767

Resorcinol

EPR0300000

Retinol acetate

EPR0290000

Retinol ester

EPR0500500

Reviparin sodium

EPY0000377

Ribavirin

20 mg 1000 mg 100 mg 250 mg 2x150 mg

EPR0600000

Riboflavin (Vitamine B2)

100 mg

EPY0000757

Riboflavin for peak identification

0.12 mg

EPR0630000

Riboflavine sodium phosphate

250 mg

EPY0000662

Ribonucleic acid

100 mg

EPY0000149

Rifabutin

150 mg

EPY0000184

Rifabutin impurity A 1-(2-methylpropyl)piperidin-4-one

20 mg

EPR0700000

Rifampicin

100 mg

EPR0800000

Rifampicin quinone

100 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

297

European Pharmacopoeia Code

Product

EPR0900000

Rifamycin B

Unit

50 mg

EPR0950000

Rifamycin S

50 mg

EPR1000000

Rifamycin sodium

300mg

EPY0001074

Rifaximin

160 mg

EPY0001075

Rifaximin for system suitability

EPY0000250

Rilmenidine dihydrogenophosphate - Reference Spectrum

EPY0000187

Rilmenidine for system suitability

30 mg

EPR1000600

Risperidone

50 mg

EPY0000370

Risperidone for system suitability

EPY0001276

Risperidone impurity K 3-[2-[4-(1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4Hpyrido[1,2a]pyrimidin-4-one (desfluoro risperidone)

10 mg unit

20 mg 0.015 mg

EPY0000714

Ritonavir

80 mg

EPY0000706

Ritonavir for peak identification

10 mg

New EPY0001485

Rivastigmine for system suitability

New EPY0001302

Rizatriptan benzoate

New EPY0001303

Rizatriptan for system suitability

1.0114 mg 200 mg 15 mg

EPR1300000

RK 13 cells cell lines (kidney,rabbit) titration of live measles, mumps and rubella vaccines

EPY0000594

Rocuronium bromide - Reference Spectrum

EPY0000527

Rocuronium for peak identification

10 mg

EPY0000742

Ropivacaine hydrochloride monohydrate

10 mg

EPY0000743

Ropivacaine impurity G (+)-(2R)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide ((R)-ropivacaine)

EPY0000786

Rosmarinic acid

EPR1500000

Roxithromycin

EPY0000220

Roxithromycin for system suitability

EPR2000000

Rubella vaccine (live) BRP

EPY0000494

Ruscogenins

EPY0000105

Rutoside trihydrate

2x1 mL

unit

5 mg 40 mg 125 mg 5 mg 5x18 mg 10 mg 100 mg

EPS0040000

Saccharin

30 mg

EPS0050000

Saccharin Sodium

50 mg

EPS0100000

Salbutamol

50 mg

EPY0000030

Salbutamol impurity B (1RS)-2-[(1,1-dimethylethyl)amino]-1-(4-hydroxyphenyl)ethanol

5 mg

EPY0000071

Salbutamol impurity D 5-[(1RS)-2-[(1,1-dimethylethyl)amino]-1-hydroxyethyl]-2hydroxybenzaldehyde

5 mg

EPY0000031

Salbutamol impurity F 1,1'[oxybis[methylene(4-hydroxy-1,3-phenylene)]]bis [2-[(1,1-dimethylethyl)amino]ethanol]

5 mg

EPY0000034

Salbutamol impurity G 2-[benzyl(1,1-dimethylethyl)amino]-1-[4-hydroxy-3-hydroxymethyl) phenyl]ethanone

5 mg

EPY0000032

Salbutamol impurity I (1RS)-2-[(1,1-dimethylethyl)amino]-1-[3-(hydroxymethyl)-4-benzyloxyphenyl] ethanol

EPY0001186

Salbutamol impurity J 2-[(1,1-dimethylethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethanone (salbutamone)

0.006 mg 0.00045 mg

EPS0150000

Salbutamol sulfate

50 mg

EPY0001288

Salbutamol sulfate for system suitability

10 mg

EPY0000669

Salicin

EPS0200000

Salicylic acid

50 mg

EPY0000405

Salicylic acid impurity B 4-hydroxyisophthalic acid

10 mg

EPY0000422

Salmeterol xinafoate

50 mg

298

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg

Edition 2012/2013

European Pharmacopoeia Code

Product

EPY0000423

Salmeterol xinafoate for system suitability

25 mg

EPY0001052

Santonin

20 mg

EPY0001049

Saquinavir mesilate

70 mg

EPY0001056 New EPY0001483

Saquinavir for system suitability Saw palmetto extract

Unit

0.3033 mg 8g

EPY0000814

Selamectin

100 mg

EPY0000815

Selamectin for system suitability

EPS0360000

Selegiline hydrochloride

50 mg

EPS0360090

(RS)-Selegiline hydrochloride

25 mg

EPS0400000

Senna extract

50 mg

5 mg

EPS0450000

Serine

EPS0460000

Sertaconazole nitrate

125 mg

50 mg

EPY0000828

Sertraline hydrochloride

200 mg

EPY0000866

Sertraline for peak identification

5.4 mg

EPY0000867

Sertraline for system suitability

6.18 mg

EPY0001285

Sertraline impurity E

15 mg

EPY0000371

Sestamibi labelling kit

22 mg

EPY0001046

Sevoflurane

EPS0500000

Silicone elastomer

1 mL 2000 mg

EPS0600000

Silicone oil

EPS0650000

Simvastatin

1 mL

EPY0001066

Simvastatin for peak identification

EPS0660000

Sisomicin sulfate

EPY0000014

Sodium alendronate

150 mg

EPS0695000

Sodium amidotrizoate

125 mg

EPY0000300

Sodium aminosalicylate dihydrate - Reference Spectrum

100 mg 10 mg 50 mg

unit

EPY0000039

Sodium ascorbate

EPS0700000

Sodium calcium edetate

100 mg

50 mg

EPS0710000

Sodium cetostearyl sulfate

100 mg

EPS0750000

Sodium cromoglicate

10 mg

EPY0001300

Sodium cromoglicate for system suitability

20 mg

EPS0760000

Sodium cyclamate

New EPY0001410

Sodium fusidate

EPS0781000

Sodium hyaluronate - Reference Spectrum

EPS0780000

Sodium hyaluronate BRP

New EPY0001468

100 mg 10 mg unit 300 mg

Sodium iodohippurate

15 mg

EPY0000620

Sodium laurilsulfate

40 mg

EPY0000808

Sodium phenylbutyrate

EPY0000809

Sodium phenylbutyrate impurity C 4-cyclohexylbutanoic acid

5 mg 10 mg

EPS0785000

Sodium picosulfate

100 mg

EPY0001104

Picosulfate for system suitability

0.5 mg

EPY0000210

Sodium polystyrene sulphonate - Reference Spectrum

unit

EPY0000268

Sodium propionate - Reference Spectrum

unit

EPS0800000

Sodium salicylate

EPS0808000

Sodium stearyl fumarate

50 mg

EPS0808060

Sodium stearyl maleate

10 mg

EPS0900000

Sodium taurocholate BRP

EPS0930000

Sodium valproate

150 mg

EPS0945000

Somatostatin

2.45 mg

EPS0947000

Somatropin

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg

10000 mg

55 mg

299

European Pharmacopoeia Code

Product

EPY0000711

Somatropin/desamidosomatropin resolution mixture

33 mg

EPS0950000

Sorbic acid

10 mg

EPY0000385

1,4-Sorbitan

50 mg

EPS1000000

Sorbitol

EPY0000114

Sotalol hydrochloride

25 mg

EPY0000115

Sotalol impurity B N-[4-[[(1-methylethyl)amino]acetyl]phenyl]methanesulphonamide

20 mg

EPY0001011

Spanish sage oil for peak identification

250 mg

EPY0000597

Spectinomycin hydrochloride

100 mg

EPY0000549

Spectinomycin for system suitability

20 mg

EPY0000655

Spectinomycin sulphate tetrahydrate

10 mg

EPY0001126

Spike lavender oil

400 µl

EPS1100000

Spiramycin

EPY0000381

Spirapril hydrochloride monohydrate

EPY0000332

Spirapril for system suitability

EPS1200000

Spironolactone

EPY0001295

Spironolactone for system suitability

Unit

1200 mg

200 mg 60 mg 15 mg 150 mg 2.055 mg

EPY0000185

Squalane

0.25 mL

EPY0001050

St.John's wort standardised dry extract

500 mg

EPY0001091

Standardised artichoke leaf dry extract

60 mg

EPS1250000

Stanozolol

50 mg

EPS1250010

Stanozolol impurity A (5α,17β)-17-hydroxy-17-methylandrostan-3-one

10 mg

New EPY0001420

Stanozolol impurity B

10 mg

EPS1300000

Starch BRP

50000 mg

EPY0000408

Stavudine

EPY0000421

Stavudine for system suitability

EPS1340000

Stearic acid Plastic additive 19

100 mg

EPS1350000

Stearyl alcohol

250 mg

100 mg 10 mg

EPY0000868

Streptokinase for system suitability

EPS1400000

Streptomycin sulphate

100 mg

30 µl

EPS1500000

Succinylsulfathiazole

100 mg

EPY0001324

Sucralfate

10 mg

EPY0001344

Sucralose

550 mg

EPY0001342

Sucralose impurity B 1,6-dichloro-1,6-dideoxy-β-D-fructofuranosyl 6-chloro-6-deoxy-α-D-glucopyranoside (1‘,6,6‘-trichloro-1‘,6,6‘-trideoxysucrose)

0.5 mg

EPS1600000

Sucrose

100 mg

EPS1608100

Sufentanil - Reference Spectrum

unit

EPS1609000

Sufentanil citrate - Reference Spectrum

unit

EPY0000529

Sulbactam sodium

EPY0000528

Sulbactam

EPY0000550

Sulbactam for peak identification

20 mg

EPS1700000

Sulfacetamide sodium

50 mg

EPS1800000

Sulfadiazine

10 mg 150 mg

100 mg

New EPY0001469

Sulfadiazine impurity A 2,6-dimethylaniline

20 mg

New EPY0001480

Sulfadiazine for identification of impurity F

15 mg

EPS1900000

Sulfadimidine

EPS1950000

Sulfadoxine

EPS1975000

Sulfafurazole

EPS1975600

Sulfaguanidine

300

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg 50 mg 100 mg 60 mg Edition 2012/2013

European Pharmacopoeia Code

Product

EPS2000000

Sulfamerazine

100 mg

Unit

EPS2050000

Sulfamethizole

100 mg

EPS2100000

Sulfamethoxazole

EPY0000412

Sulfamethoxazole impurity A N-(4-(5-methyl)-isoxazol-3-ylsulphamoyl)phenylacetamide

5 mg

EPY0000413

Sulfamethoxazole impurity F 4-amino-N-(3-methylisoxazol-5-yl)benznesulphonamide

5 mg

EPS2150000

Sulfamethoxypyridazine

EPS2151000

Sulfanilamide

EPS2159100

Sulfapyridine

20 mg

EPS2155000

Sulfasalazine

2x250 mg

EPS2155010

Sulfasalazine derivative for resolution 2-hydroxy-5-[[4-[[(6-methylpyridin-2-yl)amino]-sulfonyl]phenyl]azo]benzoic acid

50 mg

50 mg 100 mg

20 mg

EPS2158000

Sulfathiazole

EPS2159000

Sulfinpyrazone

100 mg 30 mg

EPY0001238

Sulfinpyrazone for system suitability

0.5 mg

EPS2159010

Sulfinpyrazone impurity A 1,2-diphenyl-4-(2-phenylsulphonylethyl)pyrazolidine-3,5-dione

20 mg

EPS2159015

Sulfinpyrazone impurity B 1,2-diphenyl-4-(2-phenylthioethyl)pyrazolidine-3,5-dione

20 mg

EPS2160000

Sulfisomidine

50 mg

EPS2180000

Sulindac

50 mg

EPS2190000

Sulpiride

100 mg

EPS2191000

Sulpiride impurity A [(2RS)-1-ethylpyrrolidin-2-yl]methanamine

20 mg

EPS2192000

Sulpiride impurity B methyl 2-methoxy-5-sulphamoylbenzoate

20 mg

EPY0000530

Sultamicillin

10 mg

EPY0000531

Sultamicillin tosilate

EPY0000532

Sultamicillin for peak identification

10 mg

EPY0000022

Sumatriptan succinate

50 mg

EPY0000026

Sumatriptan impurity mixture

3 mg

EPY0000027

Sumatriptan for system suitability

2 mg

EPS2200000

Suxamethonium chloride

EPS2400000

Suxibuzone

50 mg

EPS2400004

Suxibuzone impurity B (4-butyl-3,5-dioxo-1,2-diphenylpyrazolidin-4-yl)methyl ethyl butanedioate

10 mg

EPS2400006

Suxibuzone impurity C 4-butyl-4-(hydroxymethyl)-1,2-diphenyl-1,2-dihydro-4H-pyrazole-3,5-dione

10 mg

EPS5000001

Swine erysipelas bacteria, serotyp 1 (for vaccines-vet.use) BRP

1 mg

EPS5000002

Swine erysipelas bacteria, serotyp 2 (for vaccines-vet.use) BRP

1 mg

New EPY0001417 EPT0010000

Tadalafil

200 mg

1000 mg

200 mg

Talampicillin hydrochloride

50 mg

EPT0014000

Tamoxifen citrate

80 mg

EPT0015000

Tamoxifen citrate for performance test

30 mg

EPY0000650

Tamsulosin hydrochloride

10 mg

EPY0000653

Tamsulosin racemate

10 mg

EPY0000651

Tamsulosin impurity D 2-methoxy-5[(2R)-2-[[2-(2-methyoxyphenoxy)ethyl]amino]propyl]benzenesulfonamide

10 mg

EPY0000652

Tamsulosin impurity H (2R)-N-[2-(2-ethoxyphenoxy)ethyl]-1-(4-methoxyphenyl)propan-2-amine

10 mg

EPY0001102

Teicoplanin

52 mg

EPY0001047

Teicoplanin for identification

40 mg

EPY0000648

Telmisartan

30 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

301

European Pharmacopoeia Code

Product

EPY0000649

Telmisartan for peak identification

EPY0001003

Telmisartan for system suitability

EPT0040000

Temazepam Controlled Substance

EPY0000344

Temazepam impurity C (3RS)-7-chloro-1-methyl-2-oxo-5-phenyl-2,3-dihydro-1H-1,4-benzodiazepin-3-yl acetate Controlled Substance

5 mg

EPY0000345

Temazepam impurity D (3RS)-7-chloro-3-methoxy-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one Controlled Substance

5 mg

EPY0000346

Temazepam impurity F (5RS)-7-chloro-1-methyl-5-phenyl-4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione

5 mg

EPY0000347

Temazepam impurity G (5RS)-7-chloro-1,4-methyl-5-phenyl-4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione

5 mg

EPT0040800

Tenoxicam

EPY0001114

Tenoxicam impurity mixture

Unit

10 mg 0.26 mg 50 mg

100 mg 0.0042 mg

EPY0000621

Terazosin hydrochloride dihydrate

40 mg

EPY0000666

Terazosin for system suitability

0.5 mg

EPY0000622

Terazosin impurity A 2-chloro-6,7-dimethoxyquinazolin-4-amine

10 mg

EPY0000665

Terazosin impurity E 2,2`-(piperazine-1,4-diyl)bis(6,7-dimethoxyquinazolin-4-amine) Terazosin impurity L 1-(furan-2-ylcarbonyl)piperazine

10 mg

EPY0000624

Terazosin impurity N 1-[[(2RS)-tetrahydrofuran-2-yl]carbonyl]piperazine

10 mg

EPY0000535

Terbinafine hydrochloride

10 mg

EPY0001143

Terbinafine for system suitability

EPT0050000

Terbutaline sulfate

EPT0050015

Terbutaline impurity C 1-(3,5-dihydroxyphenyl)-2-[(1,1- dimethylethyl)amino]-ethanone

EPY0000623

10 mg

10 mg 100 mg 15 mg

EPT0060000

Terconazole

250 mg

EPT0071000

Terfenadine

100 mg

EPT0080000

Terfenadine impurity A 1-[4-(1,1-dimethylethyl)phenyl]-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl] butan-1-one (ketone)

20 mg

EPT0100000

Testosterone

30 mg

EPT0210000

Testosterone caproate

50 mg

EPT0240000

Testosterone decanoate

50 mg

EPY0000696

Testosterone decanoate for system suitability

0.4 mg

EPT0250000

Testosterone enantate

100 mg

EPY0001312

Testosterone enantate for peak identification

10 mg

EPY0001317

Testosterone enantate for system suitability

20 mg

EPY0001313

Testosterone enantate impurity H delta-5-testosterone-3,17-dienantate

10 mg

EPY0000342

Testosterone for impurity D identification

20 mg

EPY0000343

Testosterone for system suitability

20 mg

EPT0260000

Testosterone isocaproate

50 mg

EPY0000716

Testosterone isocaproate for system suitability

EPT0300000

Testosterone propionate

New EPY0001409

Testosterone propionate for system suitability

5 mg 60 mg 5 mg

EPT0400000

Tetanus vaccine (adsorbed) BRP

30 mg

EPY0001087

Tetra-O-acetyl-mannose triflate

60 mg

EPT0500000

Tetracaine hydrochloride

EPY0001002

Tetracaine for system suitability

EPT0550000

Tetracosactide

302

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg 2 mg 2x0.366mg

Edition 2012/2013

European Pharmacopoeia Code

Product

EPT0600000

Tetracycline hydrochloride

Unit

100 mg

EPY0001165

Tetrandrine

EPY0000015

Tetrazepam - Reference Spectrum

20 mg

EPY0000008

Tetrazepam impurity C 7-chloro-5-cyclohexyl-1-methyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one

20 mg

EPY0000460

Tetryzoline hydrochloride

10 mg

EPY0000723

Thebaine Controlled Substance

10 mg

EPT0700000

Theobromine

100 mg

EPT0800000

Theophylline

100 mg

EPY0000294

Theophylline - Reference Spectrum

unit

unit

EPY0000336

Thiamazole

EPY0000372

Thiamazol impurity A 2,2-dimethoxy-N-methylethanamine

125 mg 15 mg

EPY0000373

Thiamazol impurity C 1-methyl-2-(methylsulphanyl)-1H-imidazole

20 mg

EPY0000467

Thiamine hydrochloride

10 mg

EPY0000059

Thiamine impurity E 3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-5-(2-hydroxyethyl) 4-methyl-4-thiazolidine-2-thione

10 mg

EPY0000060

Thiamine nitrate - Reference Spectrum

unit

EPT1100000

Thiamphenicol

125 mg

EPY0000546

Thioctic acid

110 mg

EPY0000592

Thioctic acid for system suitability

10 mg

EPY0000545

Thioctic acid containing impurity B

30 mg

EPY0000109

Thiomersal

30 mg

EPT1200000

Thiopental

500 mg

New EPY0001478

Thiopental for system suitability

10 mg

EPY0000704

Thioridazine

EPT1300000

Thioridazine hydrochloride

100 mg

10 mg

EPY0000541

Thioridazine for system suitability

0.21 mg

EPT1305100

Thioxanthene

20 mg

EPT1305000

Thioxanthone

10 mg

EPT1340000

Threonine

50 mg

EPT1350000

Thymol

50 mg

EPT1410000

Tiabendazole

50 mg

EPY0000414

Tiamulin for peak identification

10 mg

EPY0000333

Tiamulin hydrogen fumarate

EPY0000379

Tiamulin - Reference Spectrum

500 mg unit

EPY0000151

Tianeptine sodium - Reference Spectrum

EPY0000152

Tianeptine for system suitability

30 mg

unit

EPY0000153

Tianeptine impurity A ethyl 7-bromoheptanoate

20 mg

EPT1405000

Tiapride hydrochloride

60 mg

EPT1405050

Tiapride N-oxide

20 mg

EPT1410900

Tiaprofenic acid

50 mg

EPT1410910

Tiaprofenic acid impurity C (2RS)-2-(5-benzoylthiophen-3-yl)propanoic acid

20 mg

EPY0000748

Tibolone - Reference Spectrum

EPY0000668

Tibolone for system suitability

unit

EPY0000465

Ticarcillin monosodium

EPT1420010

Ticarcillin impurity A (2S,5R,6R)-3,3-dimethyl-7-oxo-6-[[(thiophen-3-yl)acetyl]-amino]-4-thia-1azabicyclo[3.2.0]heptane-2-carboxylic acid (decarboxyticarcillin)

50 mg

EPT1423000

Ticlopidine hydrochloride

50 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

10 mg 250 mg

303

European Pharmacopoeia Code

Product

EPT1423025

Ticlopidine impurity F 6-(2-chlorobenzyl)4,5,6,7-tetrahydrothieno [3,2-c]pyridine

10 mg

EPY0000325

Tilidine hydrochloride hemihydrate - Reference Spectrum

unit

EPY0001270

Timolol for system suitability

EPT1450000

Timolol maleate

EPY0000644

(R)-timolol

20 mg

EPT1470000

Tinidazole

100 mg

EPY0000899

Tinidazole impurity A 2-methyl-5-nitro-1H-imidazole

10 mg

EPT1471000

Tinidazole impurity B 1-(2-ethylsulphonylethyl)-2-methyl-4-nitroimidazole

20 mg

EPT1490000

Tinzaparin sodium

EPY0000292

Tioconazole - Reference Spectrum

Unit

5.045 mg 100 mg

250 mg unit

EPY0000282

Tioconazole for system suitability

50 mg

EPY0001188

Tiotropium bromide monohydrate

10 mg

EPY0001216

Tiotropium impurity F dithiophen-2-ylmethanone

10 mg

EPY0001179

Tiotropium impurity mixture

EPY0001189

Tiotropium for system suitability

10 mg

EPT1500000

Tobramycin

51 mg

EPY0001210

Tobramycin for identification

EPY0000383

All-rac-alpha-tocopherol for peak identification

0.08 mg

250 mg 15 mg

EPY0000384

All-rac-alpha-tocopheryl acetate for peak identification

EPT1550000

alpha-Tocopherol

500 mg

30 mg

EPT1600000

alpha-Tocopheryl acetate

500 mg

EPT1610000

RRR-alpha-Tocopheryl hydrogen succinate

150 mg

EPT1700000

Tolbutamide

100 mg

EPY0000154

Tolfenamic acid

100 mg

EPT1707000

Tolnaftate

60 mg

EPY0001123

Tolnaftate for system suitability

10 mg

EPY0000461

Torasemide anhydrous

10 mg

EPY0000462

Torasemide for system suitability

EPY0001366

Torasemide impurity E ethyl [[4-[(3-methylphenyl)amino]pyridin-3-yl]sulfonyl]carbamate

EPY0000155

Tramadol hydrochloride

75 mg

EPY0000156

Tramadol impurity A (1RS,2SR)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol

15 mg

EPY0000157

Tramadol impurity E (2RS)-2-[(dimethylamino)methyl]cyclohexanone

15 mg

EPY0000072

Tramazoline hydrochloride monohydrate

20 mg

EPY0000065

Tramazoline impurity A N-(naphthalen-1-yl)-4,5-dihydro-1H-imidazol-2-amine

10 mg

EPY0000066

Tramazoline impurity B mixture of: 1-acetyl-2-[(5,6,7,8-tetrahydronaphthalen-1-yl)amino]-4,5-dihydro-1H-imidazole and N-(4,5-dihydro-1H-imidazol-2-yl)-N-(5,6,7,8-tetrahydronaphthalen-1-yl)acetamide

10 mg

EPY0000501

Trandolapril

10 mg

EPY0000495

Trandolapril impurity C (2S,3aR,7aS)-1-[(2S)-2-[[(1S)-3-cyclohexyl-1(ethoxycarbonyl)propyl]amino]propanoyl]octahydro-1H-indole-2-carboxylic acid (hexahydrotrandolapril)

10 mg

EPY0000496

Trandolapril impurity D ethyl (2S)-2-[(3S,5aS,9aR,10aS)-3-methyl-1,4-dioxodecahydropyrazino[1,2-a]indol-2(1H)-yl]4-phenylbutanoate (trandolapril diketopiperazine)

10 mg

EPT1810000

Tranexamic acid

50 mg

EPT1820000

Trapidil

50 mg

304

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

5 mg 0.0006 mg

Edition 2012/2013

European Pharmacopoeia Code

Product

EPT1820002

Trapidil impurity A 5-methyl-[1,2,4]triazolo[1,5-a]pyrimidin-7-ol

20 mg

Unit

EPT1820004

Trapidil impurity B 1,2,4-triazol-3-amine

20 mg

EPY0001172

Trehalose dihydrate

250 mg

EPT1850000

Tretinoin

EPT1899000

3,4,6-Tri-O-acetyl-D-glucal - Reference Spectrum

EPG0400010

Triacetin - Reference Spectrum

EPT1899990

Triamcinolone

150 mg

Triamcinolone acetonide

150 mg

EPT1900000 New EPY0001459

Triamcinolone acetonide for system suitability

50 mg unit unit

10 mg

EPT1950000

Triamcinolone hexacetonide

EPY0000050

Triamcinolone impurity C 9-fluoro-11ß-16alpha,17,21-tetrahydroxypregn-4-ene-3,20-dione

10 mg

EPY0000837

Triamterene

10 mg

EPY0000870

Triamterene impurity B 2,7-diamino-6-phenylpteridin-4-ol

0.5 mg

EPT1975000

Triazolam Controlled Substance

10 mg

EPY0000165

Tribenoside

EPY0000166

Tribenoside impurity A 3,5,6-tri-O-benzyl-1,2-O-(1-methylethylidene)-α-D-glucofuranose

EPY0001055

Tributyl acetylcitrate

100 mg

150 mg 60 mg 1 mL

EPY0000279

Tri-n-butyl phosphate

300 µL

EPY0000799

Tributyl acetylcitrate for peak identification

25 mg

EPT1977990

Tricaprin

150 mg

EPT1977995

Tricaproin

40 mg

EPT1978000

Tricaprylin

225 mg

EPY0000111

Trichloroacetic acid - Reference Spectrum

EPT1985000

Trichlorotrifluoroethane

EPT1986000

Triethyl citrate - Reference Spectrum

EPT2000000

Trifluoperazine hydrochloride

unit 2.5 mL unit 100 mg

EPT2005000

Triflusal

50 mg

EPT2005010

Triflusal impurity B 2-hydroxy-4-(trifluoromethyl)benzoic acid

25 mg

EPY0000720

Triglycerol diisostearate

200 mg

EPY0000108

Trihexyphenidyl hydrochloride

100 mg

EPY0000068

Trihexyphenidyl impurity A 1-phenyl-3-(piperidin-1-yl)propan-1-one

EPT2009000

Trilaurin

1250 mg

EPY0001260

Trimebutine for system suitability

1.017 mg

EPY0001319

Trimebutine maleate

EPY0000092

Trimetazidine dihydrochloride - Reference Spectrum

EPY0000093

Trimetazidine for system suitability

EPT2100000

Trimethadione

EPT2200000

Trimethoprim

EPY0000684

Trimethoprim for system suitability

EPT2200010

Trimethoprim impurity B (2,4-diaminopyrimidin-5-yl)(3,4,5- trimethoxyphenyl)methanone

EPT2450000

Trimethyltetradecylammonium bromide

20 mg

10 mg unit 50 mg 250 mg 50 mg 0.00075 mg 15 mg 200 mg

EPT2500000

Trimipramine maleate

100 mg

EPY0000759

Trimipramine for peak identification

0.51 mg

EPT2500100

Trimyristin

500 mg

EPT2501200

Tristearin

100 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

305

European Pharmacopoeia Code

Product

EPT2545000

Trolamine

Unit

EPY0001184

Trolamine impurity A Ethanolamine

250 mg

EPY0001183

Trolamine impurity B Diethanolamine

1 mL

EPT2550000

Trometamol

100 mg

EPT2580000

Tropicamide

50 mg

EPY0001316

Tropicamide for peak identification

10 mg

EPY0001247

Tropicamide impurity C (2RS)-3-hydroxy-2-phenylpropanoic acid (tropic acid)

10 mg

EPY0001248

Tropicamide impurity D Phenylacetic acid Drug Precursor

10 mg

EPY0000616

Tropisetron hydrochloride

40 mg

EPY0000618

Tropisetron impurity B 1H-indole-3-carboxylic acid

10 mg

EPT2580300

Tropine

50 mg

EPY0000429

Trospium chloride

10 mg

EPY0000432

Trospium impurity A Hydroxydiphenylacetic acid (benzilic acid)

20 mg

EPY0000431

Trospium impurity B (1R,3r,5S)-8-azabicyclo[3.2.1]oct-3-yl hydroxydiphenylacetate

20 mg

EPY0000430

Trospium impurity C (1R,3r,5S)-3-hydroxyspiro[8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium]

EPY0000497

Troxerutin

EPT2600000

Trypsin BRP

100 mg

EPT2610000

Tryptophan

100 mg

EPT2800000

Tubocurarine chloride

100 mg

EPT2880000

Tylosin

150 mg

2250 mg

5 mg 30 mg

EPT2880100

Tylosin D

EPY0000498

Tylosin phosphate for peak identification

5 mg

EPT2880200

Tylosin tartrate - Reference Spectrum

EPT2900000

Tyrosine

50 mg

EPT3000000

Tyrothricin

20 mg

EPU0020000

Ubidecarenone

50 mg

EPU0020001

Ubidecarenone for system suitability

1 mg

EPU0020008

Ubidecarenone impurity D 5,6-dimethoxy-3-methyl-2-[(all-E)-3,7,11,15,19,23,27,31,35nonamethylhexatriaconta-2,6,10,14,18,22,26,30,34-nonaenyl] benzene-1,4-dione

5 mg

EPU0100000

Uracil arabinoside

EPU0600000

Urea

10 mg unit

60 mg 100 mg

EPU0800000

Ursodeoxycholic acid

100 mg

EPY0001163

Ursodeoxycholic acid for system suitability

1.26 mg

New EPY0001523

Ursolic acid

25 mg

EPY0001225

Valaciclovir for system suitability

10 mg

EPY0000834

Valaciclovir hydrochloride (anhydrous)

EPY0001096

Valaciclovir impurity D 2-[(2-amino-6-oxo-1,6dihydro-9H-purin-9-yl)methoxy]ethyl N-ethyl-L-valinate

10 mg

EPY0001097

Valaciclovir impurity E 2-[(2-amino-6-oxo-1,6dihydro-9H-purin-9-yl)methoxy]ethyl N-[(benzyloxy)carbonyl]-L-valinate

10 mg

EPY0001098

Valaciclovir impurity F para-toluenesulfonate 2-hydroxyethyl L-valinate

12 mg

EPY0001099

Valaciclovir impurity G N,N-dimethylpyridin-4-amine

10 mg

EPY0000583

Valerian standardised dry extract

EPV0030000

Valine

306

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg

400 mg 50 mg Edition 2012/2013

European Pharmacopoeia Code

Product

EPY0000584

Valnemulin hydrochloride

Unit

EPY0000533

Valnemulin hydrogen tartrate

EPY0000585

Valnemulin for peak identification

20 mg

EPY0000586

Valnemulin impurity E (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxodecahydro3a,9-propano-3aH-cyclopenta[8]annulen-8-yl 2-hydroxyacetate (pleuromulin)

10 mg

EPV0033000

Valproic acid

10 mg 120 mg

100 mg

Valproic acid for system suitability

10 mg

EPY0001132

Valsartan

10 mg

EPY0001131

Valsartan for peak identification

EPY0001145

Valsartan for system suitability

EPV0045000

Vancomycin hydrochloride

100 mg

EPV0050000

Vanillin

100 mg

EPY0001198

Varicella vaccine (live)

420 mg

New EPY0001422

10 mg 0.202 mg

EPY0000561

Vecuronium bromide

10 mg

EPY0000625

Vecuronium for peak identification

10 mg

EPY0001093

Vedaprofen

EPY0001118

Vedaprofen impurity mixture

EPY0000587

Venlafaxine hydrochloride

EPY0000588

Venlafaxine for system suitability

EPV0100000

Verapamil hydrochloride

EPV0100018

Verapamil impurity I (2RS)-2-(3,4-dimethoxyphenyl)-2-[2-[[2-(3,4)dimethoxyphenyl)ethyl](methyl)amino]ethyl]3-methylbutanenitrile

EPV0100026

Verapamil impurity M 5,5'-[[2-(3,4)dimethoxyphenyl)ethyl]imino]bis[2-(3,4-dimethoxyphenyl)2-(1-methylethyl)pentanenitrile

5 mg 0.006 mg 50 mg 1 mg 100 mg 5 mg

10 mg

EPY0000661

Verbenalin

11 mg

EPV0180000

VERO cells

2x1 mL

New EPY0001400

Vigabatrin

10 mg

New EPY0001401

Vigabatrin impurity A (5RS)-5-ethenylpyrrolidin-2-one

25 mg

New EPY0001402

Vigabatrin impurity B (2E)-2-(2-aminoethyl)but-2-enoic acid

20 mg

New EPY0001404

Vigabatrin impurity D 4-aminobutanoic acid

50 mg

New EPY0001403

Vigabatrin impurity E 2-[(2RS)-2-aminobut-3-enyl]propanedioic acid

10 mg

EPV0200000

Viscosimeter calibration liquids

EPV0300000

Vinblastine sulphate

EPV0305000

Vinblastine sulfate - Reference Spectrum

EPV0400000

Vincristine sulphate

EPV0405000

Vincristine sulfate - Reference Spectrum

EPV0500000

Vindesine sulphate

EPV0500010

Vindesine sulfate - Reference Spectrum

EPY0000463

Vinorelbine tartrate

EPY0000464

Vinorelbine impurity B 4-O-deacetylvinorelbine

250 mL 5 mg unit 4.98 mg unit 5.11 mg unit 50 mg 7 mg

EPY0000589

Vinpocetine

10 mg

EPY0000590

Vinpocetine impurity A (12RS,13aSR,13bSR)-13a-ethyl-12-hydroxy-2,3,5,6,12,13,13a,13b-octahydro-1Hindolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (ethyl vincaminate)

10 mg

EPY0000591

Vinpocetine impurity B (13aS,13bS)-13a-ethyl-2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1ij][1,5]naphthyridine-12-carboxylate (apovincamine)

10 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

307

European Pharmacopoeia Code

Product

EPY0000790

Vinpocetine impurity C ethyl(13aS,13bS)-13a-ethyl-9-methoxy-2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (methoxyvinpocetine)

10 mg

Unit

EPY0000760

Vinpocetine impurity D (12RS,13aRS,13bRS)-13a-ethyl-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (dihydrovinpocetine)

10 mg

EPY0000793

Vinyl acetate

200 mg

New EPY0001395

Voriconazole

120 mg

New EPY0001396

Voriconazole impurity B (2RS,3SR)-2-(2,4-difluorophenyl)-3-pyrimidin-4-yl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol

10 mg

New EPY0001398

Voriconazole impurity D (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (epi-voriconazole)

10 mg

New EPY0001397

Voriconazole impurity E [(1R,4S)-7,7-dimethyl-2-oxobicyclo[2.2.1]hept-1-yl]methanesulfonic acid ((+-)camphorsulfonic acid)

50 mg

EPW0100000

Warfarin sodium

10 mg

EPY0000778

Warfarin sodium clathrate

10 mg

EPX0075000

Xylazine hydrochloride

EPY0000158

Xylazine impurity C 2,6-dimethylphenyl isothiocyanate

50 mg

EPY0000159

Xylazine impurity E N-(2,6-dimethylphenyl)-S-methyldithiourea

15 mg

EPY0001224

Xylazine impurity mixture

125 mg

0.02 mg

EPX0080000

Xylitol

500 mg

EPX0100000

Xylometazoline Hydrochloride

100 mg

EPX0101000

Xylometazoline impurity A N-(2-aminoethyl)-2-(4-1,1-dimethylethyl-2,6-dimethylphenyl)acetamide

EPX0200000

Xylose

EPY0000656

Yohimbine hydrochloride

20 mg

EPZ1900000

Zidovudine

60 mg

EPZ1902000

Zidovudine impurity A 1-[(2R,5S)-5-hydroxymethyl-2,5-dihydro-2-furyl]-5-methylpyrimidine-2,4(1H,3H)-dione

10 mg

EPZ1904000

Zidovudine impurity B 1-(3-chloro-2,3-dideoxy-ß-D-ribofuranosyl)-5-methylpyrimidine-2,4(1H,3H)-dione

10 mg

EPZ2000000

Zinc acexamate

50 mg

EPZ2000010

Zinc acexamate impurity A 6-[[6-(acetylamino)hexanoyl]amino] hexanoic acid

50 mg

EPY0001272

Ziprasidone for system suitability 1

10 mg

EPY0001241

Ziprasidone for system suitability 2

0.465 mg

EPY0001286

Ziprasidone hydrochloride monohydrate

100 mg

EPZ2500000

Zolpidem tartrate Controlled Substance

200 mg

EPZ2500010

Zolpidem impurity A N,N'-dimethyl-2-[7-methyl-2-(4-methylphenyl)imidazol [1,2-a]pyridin-3-yl] acetamide

10 mg

EPZ3000000

Zopiclone Controlled Substance

60 mg

EPZ3001000

Zopiclone oxide

20 mg

EPY0000062

Zuclopenthixol decanoate - Reference Spectrum

EPY0000534

Zuclopenthixol for system suitability

0.1 mg

EPY0000083

Zuclopenthixol impurity B 2-chloro-9H-thioxanthen-9-one

10 mg

308

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

10 mg 100 mg

unit

Edition 2012/2013