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
