欧洲药典EP——欧洲药品质量管理局 （European   Directorate   for   the Quality of Medicines，简称EDQM ）是负责欧洲药典质量标准起草及标准物质制备的机构，目前有 35 个成员国和 18 个观察员国，其中有欧盟以及欧盟的24 个成员国。欧洲药典作为法定质量标准在欧洲34 个成员国中执行，是国际影响力的药典之一。我国于 1994 年成为 EDQM  的观察员国。所有在欧洲销售的原料药、植物药和药物制剂中使用的原料药包括辅料都必须通过 EDQM 的CEP  （Certification of Suitability of European Pharmacopoeiamonographs ）认证。该机构同时还负责欧洲药品质量监督的技术组织工作。

    欧洲药典收载的人用原料药品种，不仅数量多，覆盖面广，而且标准质量和水平也比较高，并在某些方面具有突出特点。如各论中有关物质检查，除广泛采用TLC 法，HPLC 法和杂质对照品外，对有些原料药还附有可能产生的杂质名称和它的化学结构式，甚至有的品种还绘制出色谱图象，可以全面直观地了解各种杂质，以利于对检出杂质的判断。在鉴别实验项下规定首选和次选项目，可以避免鉴别项目设置过多，而造成人力物力的浪费。在采用 TLC  法项下，广泛设置方法学的确证实验，以保证实验的可靠性。

A0040000 Acebutolol hydrochloride
A0070000 Acesulfame potassium
A0070020 Acesulfame potassium impurity B
A0100000 Acetazolamide
A0150000 Acetylcysteine
A0152000 Acetylcysteine impurity C
A0153000 Acetylcysteine impurity D
A0200000 Acetylsalicylic acid
A0202000 N-Acetyltyrosine
A0208000 N-Acetyltryptophan
A0220000 Aciclovir
A0225000 Acitretin
A0230000 Adenine
A0230200 Adenosine
A0300000 Adrenaline tartrate
A0325000 Alanine
A0325100 Albendazole
A0325200 Alcuronium chloride
A0325450 Alfacalcidol
A0325451 Alfacalcidol - reference spectrum
A0325500 Alfentanil hydrochloride - reference spectrum
A0325800 Alfuzosin hydrochloride
A0349000 Allantoin
A0350000 Allopurinol
A0350010 Allopurinol impurity A
A0350020 Allopurinol impurity B
A0350030 Allopurinol impurity C
A0350040 Allopurinol impurity D
A0350050 Allopurinol impurity E
A0351000 Allylstrychnine bromide
A0357000 Alprazolam  
A0360000 Alprenolol hydrochloride
A0363000 Amantadine hydrochloride
A0363700 Ambroxol hydrochloride
A0365000 Amidotrizoic acid dihydrate
A0365900 Amikacin sulfate
A0368000 Amikacin
A0370000 Amiloride hydrochloride
A0420000 Aminocaproic acid
A0460000 7-Aminodesacetoxycephalosporanic acid
A0496000 Aminoglutethimide
A0496005 Aminoglutethimide impurity A
A0496020 Aminoglutethimide impurity D
A0575000 Amiodarone hydrochloride
A0590000 Amisulpride
A0650000 Amobarbital  
A0700000 Amobarbital sodium  
A0800000 Amoxicillin trihydrate
A0900000 Amfetamine sulfate - reference spectrum
A1000000 Ampicillin (anhydrous)
A1100000 Ampicillin trihydrate
A1200000 Anhydrotetracycline hydrochloride
A1202000 Citric acid (anhydrous)
A1202800 Ethanol (anhydrous) - reference spectrum
A1206000 Lactose (anhydrous)
A1210000 Antazoline hydrochloride
A1225000 Alfadex
A1250000 Aprotinin solution BRP
A1269000 L-Arabinitol
A1270000 Arginine
A1271000 Arginine hydrochloride
A1300000 Ascorbic acid
A1320000 Aspartame
A1321000 Aspartame impurity A
A1330000 Aspartic acid
A1340000 Atenolol
A1400000 Atropine sulfate
A1500000 Azathioprine

B0070000 Bacampicillin hydrochloride
B0100000 Bacitracin zinc
B0200000 Baclofen
B0200050 Baclofen impurity A
B0250000 Bambuterol hydrochloride
B0300000 Barbital  
B0305000 Beclometasone dipropionate anhydrous
B0400000 Bendroflumethiazide
B0470000 Benperidol
B0477000 Benserazide hydrochloride
B0477010 Benserazide impurity A
B0490000 Benzarone
B0500000 Benzathine benzylpenicillin
B0550000 Benzethonium chloride
B0600000 Benzocaine
B0650000 Hydrous benzoyl peroxide - reference spectrum
B0670000 Benzyl benzoate - reference spectrum
B0680000 S-Benzylmercaptoacetyltriglycine
B0700000 Benzylpenicillin potassium
B0900000 Benzylpenicillin sodium
B0950000 Betadex
B0990000 Betahistine mesilate
B1000000 Betamethasone
B1030000 Betamethasone acetate
B1040000 Betamethasone dipropionate
B1045000 Betamethasone sodium phosphate
B1054000 Betamethasone 17-valerate
B1055000 Betamethasone 21-valerate
B1103000 Betaxolol hydrochloride
B1103100 Betaxolol impurity A
B1110000 Bifonazole
B1115000 Bezafibrate
B1116000 Biotin
B1120000 Biperiden hydrochloride
B1121000 Biperiden impurity A
B1140000 Bisacodyl
B1141000 Bleomycin sulfate
B1142000 Bordetella pertussis mouse antiserum BRP
B1143000 Bromazepam  
B1145000 Bromhexine hydrochloride
B1150000 Bromocriptine mesilate
B1152000 Bromperidol
B1152050 Bromperidol decanoate
B1153000 Brompheniramine maleate
B1156000 Bufexamac
B1157300 Budesonide
B1157400 Buflomedil hydrochloride
B1157410 Buflomedil impurity B
B1158000 Bumetanide
B1160000 Bupivacaine hydrochloride
B1168000 Buserelin
B1168020 D-His-Buserelin
B1170000 Busulfan
B1212000 Butylhydroxyanisole
B1215000 Butylhydroxytoluene
B1217000 Butyl parahydroxybenzoate
B1220000 Ibuprofen impurity B
C0100000 Caffeine
C0166000 Calcifediol
C0166001 Calcifediol - reference spectrum
C0200000 Calcitonin (salmon)
C0200010 N-acetyl-cys1-calcitonin
C0225000 Calcitriol
C0226000 Calcitriol - reference spectrum
C0249000 Calcium ascorbate - reference spectrum
C0250000 Calcium folinate
C0299000 Calcium glucoheptonate
C0300000 Calcium gluconate
C0340000 Calcium levulinate dihydrate
C0350000 Calcium oxalate monohydrate
C0400000 Calcium pantothenate
C0405000 Camphor (racemic)
C0410000 Canrenone
C0426000 Caprylic acid
C0430000 Captopril
C0450000 Carbamazepine
C0451000 Carbasalate calcium - reference spectrum
C0455000 Carbenicillin sodium
C0460000 Carbidopa
C0465000 Carbimazole
C0470000 Carbocisteine
C0499900 Carbon dioxide - reference spectrum
C0550000 Carboplatin - reference spectrum
C0580004 Carmustine - reference spectrum
C0580010 Carmustine impurity A
C0600000 Casein BRP
C0630000 Cefaclor
C0640000 Delta-3-Cefaclor
C0650000 Cefadroxil
C0675000 Cefalexin monohydrate
C0682000 Cefalotin sodium
C0682300 Cefamandole nafate
C0682400 Cefatrizine propylene glycol
C0682410 Cefatrizine impurity A
C0682800 Cefazolin
C0684000 Cefixime
C0684750 Cefoperazone dihydrate
C0684800 Cefoperazone sodium - reference spectrum
C0685000 Cefotaxime sodium
C0688000 Cefoxitin sodium
C0690000 Cefradine
C0690500 Ceftazidime
C0691000 Ceftriaxone sodium
C0692000 Ceftriaxone impurity A
C0694990 Cefuroxime axetil
C0695000 Cefuroxime sodium
C0700000 Cephaeline hydrochloride
C0980650 Cetirizine dihydrochloride
C0980651 Cetirizine impurity A
C0984100 Cetostearyl isononanoate - reference spectrum
C0990000 Cetyl alcohol
C1000000 Cetylpyridinium chloride
C1050000 Chenodeoxycholic acid
C1100000 Chlorambucil
C1200000 Chloramphenicol
C1300000 Chloramphenicol dipalmitate
C1350000 Chloramphenicol disodium disuccinate
C1400000 Chloramphenicol palmitate isomer
C1425000 Chloramphenicol sodium succinate
C1435000 Chlorcyclizine hydrochloride