欧洲药典标准品EP

欧洲标准品EDQM

EDQM标准物质是经过专门筛选的,并由欧洲药典委员会对检验后的标准物质进行确认。这些标准物质可在鉴别试验、有关物质检查、含量测定等药物分析中用作对照品,也可用于仪器的校正。

在WHO生物制品标准化专家委员会第56次会议上,EDQM被指定为WHO抗生素 标准品(ISA)协作标定与分发中心。WHO抗生素 标准品通常是用于建立实验室日常用于检查和含量测定的地区或国家二级标准品。

C1100000 Chlorambucil 100 mg

C1200000 Chloramphenicol 500 mg

C1300000 Chloramphenicol dipalmitate 100 mg

C1350000 Chloramphenicol disodium disuccinate 25 mg

C1400000 Chloramphenicol palmitate isomer 100 mg

C1425000 Chloramphenicol sodium succinate 1500 mg

C1435000 Chlorcyclizine hydrochloride 100 mg

C1450000 Chlordiazepoxide – * psy 50 mg

C1500000 Chlordiazepoxide hydrochloride – * psy 100 mg

Y0000476 Chlordiazepoxide impurity A 10 mg

C1510000 Chlorhexidine 50 mg

C1520000 Chlorhexidine diacetate 10 mg

C1540000 Chlorhexidine dihydrochloride 50 mg

C1530000 Chlorhexidine for performance test 50 mg

Y0000569 Chlorogenic acid 20 mg

C1600000 Chloromethylnitroimidazole 100 mg

C1605000 (2-Chlorophenyl)diphenylmethanol 20 mg

C2223030 1-(4-Chlorophenyl)-1-phenylethanol 20 mg

C1650000 Chloroquine sulphate 200 mg

C1700000 Chlorothiazide 100 mg

C1800000 Chlorphenamine maleate 100 mg

Y0000436 Chlorphenamine impurity A 0.01 mg

Y0000437 Chlorphenamine impurity C 10 mg

C1900000 Chlorpromazine hydrochloride 200 mg

Y0000507 Chlorpromazine impurity A 10 mg

Y0000479 Chlorpromazine impurity D 10 mg

Y0000508 Chlorpromazine impurity E 10 mg

C1905000 Chlorpropamide 100 mg

C1905020 Chlorpropamide impurity B 50 mg

C1915000 Chlorprothixene hydrochloride 50 mg

C1950000 Chlortalidone 150 mg

Y0000779 Chlortalidone for peak identification 1 mg

C2000000 Chlortetracycline hydrochloride 100 mg

C2100000 Cholecalciferol 500 mg

C2150000 Cholecalciferol for performance test 1 ml

C2155000 Cholesterol 60 mg

C2158000 Cholic acid 60 mg

Y0000280 Chondroitin sulphate sodium 250 mg

Y0000593 Chondroitin sulphate sodium (marine) 100 mg

C2160000 Chymotrypsin BRP 100 mg

Y0000639 Cladribine 50 mg

Y0000609 Cladribine for peak identification 10 mg

Y0000610 Cladribine impurity C 5 mg

Y0000040 Ciclopirox 100 mg

C2162701 Ciclopirox impurity A 20 mg

C2162702 Ciclopirox impurity B 20 mg

C2162700 Ciclopirox olamine 150 mg

C2163000 Ciclosporin 120 mg

Y0000361 Ciclosporin for system suitability 5 mg

C2170000 Cilastatin sodium 10 mg

C2174000 Cilazapril 50 mg

C2174002 Cilazapril impurity A 25 mg

C2174005 Cilazapril impurity D 10 mg

C2175000 Cimetidine 50 mg

C2175500 Cimetidine hydrochloride 100 mg

C2177000 Cinchocaine hydrochloride 60 mg

C2285000 Clobetasone butyrate 50 mg

Y0000313 Clofazimine 150 mg

Y0000358 Clofazimine for system suitability 10 mg

C2300000 Clofibrate 0.5 ml

C2320000 Clomifene citrate 50 mg

C2332000 Clomifene citrate for performance test 50 mg

C2360000 Clomipramine hydrochloride 100 mg

Y0000132 Clomipramine impurity C 10 mg

Y0000133 Clomipramine impurity D 10 mg

Y0000134 Clomipramine impurity F 5 mg

C2385000 Clonazepam – * psy 50 mg

C2385010 Clonazepam impurity A 25 mg

C2385015 Clonazepam impurity B 25 mg

Y0000286 Clonazepam – reference spectrum n/a

C2400000 Clonidine hydrochloride 100 mg

Y0000801 Clonidine impurity B 20 mg

Y0000833 Clopamide 40 mg

Y0000848 Clopamide for system suitability 10 mg

Y0000392 Closantel sodium dihydrate 20 mg

Y0000393 Closantel for system suitability 20 mg

C2424400 Clostridia (multi-component) rabbit antiserum(for vaccines-vet.use)BRP1 mg

C2424550 Clostridium tetani guinea pig antiserum (for vaccines – human use) BRP1 mg

C2424500 Clostridium tetani guinea pig antiserum (for vaccines – vet. use) BRP 1 mg

C2425600 Clostridium tetani rabbit antiserum (for vaccines – vet. use) BRP 1 mg

C2430000 Clotrimazole 100 mg

C3200000 Cyclobenzaprine hydrochloride 100 mg

C3230000 “Cyclohexa-1,4-dienylglycine” 20 mg

C3245000 Cyclopentolate hydrochloride 60 mg

C3250000 Cyclophosphamide 50 mg

C3280000 Cyproheptadine hydrochloride 30 mg

C3283000 Cyproterone acetate 30 mg

C3290000 Cysteine hydrochloride monohydrate 50 mg

C3300000 Cystine 100 mg

C3350000 Cytarabine 150 mg

Y0000733 Dacarbazine 20 mg

Y0000734 Dacarbazine impurity A 10 mg

Y0000735 Dacarbazine impurity B 10 mg

D0070000 Dalteparin sodium 250 mg

Y0000600 Danaparoid sodium 10 mg

D0100000 Dapsone 100 mg

D0125000 Daunorubicin hydrochloride 100 mg

D0120000 Daunorubicinone 10 mg

D0160000 Deferoxamine mesilate 30 mg

D0201000 Dehydrohexetidine 50 mg

Y0000611 Dembrexine hydrochloride monohydrate 10 mg

D0300000 Demeclocycline hydrochloride 100 mg

D0350000 N-Demethylerythromycin A 10 mg

Y0000228 Demethylflumazenil – reference spectrum n/a

D0406000 Deoxyminoxidil 0.25 mg

D0406200 Deptropine citrate 60 mg

D0430000 Dequalinium chloride 50 mg

D0431000 Dequalinium chloride for performance test 50 mg

D0480000 Desacetylvinblastine 1 mg

Y0000807 Desflurane impurity A 1 ml

D0500000 Desipramine hydrochloride 100 mg

D0600000 Deslanoside 150 mg

D0630000 Desmethylmetrifonate 30 mg

D0650000 Desmopressin 0.98 mg

Y0000509 Desogestrel 50 mg

Y0000510 Desogestrel for system suitability 10 mg

D0400000 Desoxycortone acetate 250 mg

Y0000001 Detomidine hydrochloride 100 mg

D0660020 Detomidine impurity B 20 mg

D0700000 Dexamethasone 60 mg

D0710000 Dexamethasone acetate 100 mg

Y0000538 Dexamethasone isonicotinate 10 mg

Y0000511 Dexamethasone isonicotinate for impurity C identification 10 mg

D0718000 Dexamethasone pivalate 50 mg

D0720000 Dexamethasone sodium phosphate 50 mg

D0720800 Dexchlorpheniramine maleate 60 mg

D0730000 Dexpanthenol 5 mg

D0731000 Dextran 25 mg

D0731005 Dextran 1 50 mg

D0732000 Dextran Vo 10 mg

D0733000 Dextran 4 for calibration 50 mg

D0734000 Dextran 10 for calibration 50 mg

D0735000 Dextran 40 for calibration 50 mg

D0736000 Dextran 70 for calibration 50 mg

D0737000 Dextran 250 for calibration 50 mg

D0738000 Dextran 40 for performance test 50 mg

D0739000 Dextran 60/70 for performance test 50 mg

Y0000744 Dextranomer 50 mg

D0740000 Dextromethorphan hydrobromide 100 mg

Y0000261 Dextromethorphan impurity A 5 mg

D0750000 Dextropropoxyphene hydrochloride – reference spectrum n/a

D0940000 Diazepam – * psy 30 mg

Y0000596 Diazepam for system suitability – * psy 0.5 mg

D0950000 Diazoxide 50 mg

D0970000 Dibenzocycloheptene 20 mg

D1000000 Dibenzosuberone 100 mg

Y0000480 Dibrompropamidine diisetionate 10 mg

Y0000481 Dibrompropamidine for system suitability 20 mg

D1010000 Dibutyl phthalate 1 ml

Y0000275 Dichlorodiaminocyclohexaneplatinum 10 mg

Y0000259 Diclazuril for system suitability 20 mg

Y0000264 Diclazuril for veterinary use – reference spectrum n/a

D1039990 Diclofenac potassium 100 mg

D1040000 Diclofenac impurity A 0.005 mg

D1050000 Dicloxacillin sodium 250 mg

D1060000 Dicycloverine hydrochloride 100 mg

Y0000439 Didanosine 10 mg

D2880000 Dirithromycin 100 mg

D2900000 Disodium edetate 100 mg

D2920000 Disopyramide 100 mg

D2922000 Disopyramide phosphate 100 mg

D2950000 Disulfiram 100 mg

D2953000 Dithranol 125 mg

D2953025 Dithranol impurity C 20 mg

D2953050 Dithranol impurity D 20 mg

D2954000 Dobutamine hydrochloride 100 mg

D2954600 Docosahexaenoic acid ethyl ester 150 mg

D2954500 Docusate sodium – reference spectrum n/a

Y0000365 Dodecyl gallate 30 mg

D2955000 Domperidone 150 mg

D2957000 Domperidone maleate 150 mg

D2960000 Dopamine hydrochloride 50 mg

Y0000612 Dopexamine dihydrochloride 10 mg

Y0000613 Dopexamine impurity B 10 mg

Y0000614 Dopexamine impurity F 10 mg

Y0000726 Dorzolamide hydrochloride n/a

Y0000727 Dorzolamide impurity A 5 mg

Y0000750 Dorzolamide for system suitability 5 mg

D2962000 Dosulepin hydrochloride 100 mg

D2962005 Dosulepin impurity A 50 mg

D2963000 Doxapram hydrochloride 50 mg

Y0000208 Doxapram impurity B 10 mg

Y0000553 Doxazosin mesilate 60 mg

Y0000551 Doxazosin impurity D 10 mg

E1000000 Ergometrine maleate – * Drug Precursor 50 mg

E1100000 Ergosterol 20 mg

E1200000 Ergotamine tartrate – * Drug Precursor 100 mg

Y0000051 Erysipelas ELISA coating antigen BRP 0.4 mg

Y0000177 Erythritol 1000 mg

E1300000 Erythromycin 250 mg

E1305000 Erythromycin A 250 mg

E1310000 Erythromycin B 50 mg

E1320000 Erythromycin C 50 mg

E1400000 Erythromycin estolate 100 mg

E1500000 Erythromycin ethylsuccinate 100 mg

E1500800 Erythromycin stearate 50 mg

E1515000 Erythropoietin BRP 37.5 mg

Y0000324 Esketamine hydrochloride – reference spectrum n/a

Y0000338 Esketamine impurity D – * narc 10 mg

Y0000749 Essential oil 1000 mg

E1600000 Estradiol benzoate 250 mg

Y0000201 Estradiol benzoate impurity E 10 mg

Y0000045 Estradiol butyrate 10 mg

E1620000 Estradiol hemihydrate 100 mg

Y0000314 Estradiol for peak identification 10 mg

Y0000046 Estradiol valerate 50 mg

E1680000 Estriol 50 mg

E1680005 Estriol impurity A 20 mg

E1700000 Estrone 15 mg

E1800000 Etacrynic acid 100 mg

E1830000 Etamsylate 30 mg

E1840000 Ethacridine lactate monohydrate 50 mg

E1850000 Ethambutol hydrochloride 250 mg

Y0000803 Ethambutol for system suitability 10 mg

A1202800 Ethanol (anhydrous) – reference spectrum n/a

E1860100 Ethanol 96% – reference spectrum n/a

E1900000 Ethinylestradiol 100 mg

E2000000 Ethionamide 100 mg

E2150000 Ethosuximide 30 mg

E2250000 Ethosuximide impurity A 15 mg

E2195000 Ethyl acetate – reference spectrum n/a

E2195900 Ethylcellulose – reference spectrum n/a

E2202000 1-N-Ethylgaramine sulphate 125 mg

E2205500 “1,1′-Ethylidenebistryptophan” 5 mg

Y0000617 Ethyl indole-3-carboxylate 10 mg

E2300000 Ethylmorphine hydrochloride – reference spectrum n/a

E2400000 Ethylnicotinamide 150 mg

E2425000 Ethyl parahydroxybenzoate 50 mg

E2450000 Etifenin 25 mg

E2451000 Etilefrine hydrochloride 75 mg

E2451010 Etilefrine impurity A 20 mg

Y0000572 Etidronate disodium 10 mg

E2470000 Etodolac 60 mg

E2470050 Etodolac impurity H 10 mg

Y0000768 Etodolac for peak identification 10 mg

E2499900 Etofenamate 40 mg

E2499901 Etofenamate for peak identification 15 mg

E2499914 Etofenamate impurity G 20 mg

E2500000 Etofylline 100 mg

E2503000 Etomidate 100 mg

E2503004 Etomidate impurity B 25 mg

E2600000 Etoposide 150 mg

E5000000 Eugenol 500 Pl

F0005000 Famotidine 100 mg

Y0000382 Famotidine for system suitability 10 mg

F0006000 Famotidine impurity A 10 mg

F0007000 Famotidine impurity B 10 mg

Y0000409 Famotidine impurity D 10 mg

Y0000556 Febantel 110 mg

Y0000660 Febantel for system suitability 10 mg

Y0000731 Felbinac 10 mg

Y0000732 Felbinac impurity A 20 mg

F0030000 Felodipine 120 mg

Y0000415 Felypressin 0.994 mg

F0040000 Fenbendazole 150 mg

F0040010 Fenbendazole impurity A 20 mg

F0040020 Fenbendazole impurity B 20 mg

F0041000 Fenbufen 100 mg

F0048000 Fenofibrate 100 mg

F0048005 Fenofibrate impurity A 20 mg

F0048010 Fenofibrate impurity B 10 mg

F0048035 Fenofibrate impurity G 25 mg

Y0000756 Fenoterol for peak identification 1.2 mg

F0050000 Fenoterol hydrobromide 100 mg

F0051000 Fenoterol hydrobromide – reference spectrum n/a

F0054990 Fentanyl – reference spectrum n/a

F0055000 Fentanyl citrate – reference spectrum n/a

F0060000 Fenticonazole nitrate 50 mg

F0060040 Fenticonazole impurity D 20 mg

F0100000 Ferrous gluconate 1000 mg

Y0000789 Fexofenadine hydrochloride 60 mg

Y0000751 Fexofenadine impurity A 5 mg

Y0000752 Fexofenadine impurity B 0.01 mg

Y0000753 Fexofenadine impurity C 5 mg

Y0000090 Finasteride 50 mg

Y0000091 Finasteride for system suitability 100 mg

Y0000736 Flavoxate hydrochloride 10 mg

Y0000737 Flavoxate impurity A 10 mg

Y0000738 Flavoxate impurity B 10 mg

F0120000 Flecainide acetate 200 mg

F0120005 Flecainide impurity A 50 mg

F0120010 Flecainide impurity B 25 mg

Y0000138 Flubendazole 25 mg

Y0000139 Flubendazole for system suitability 20 mg

Y0000892 Flucloxacillin magnesium octahydrate 5 mg

Y0000890 Flucloxacillin impurity D 5 mg

F0150000 Flucloxacillin sodium 250 mg

Y0000557 Fluconazole 50 mg

F0189900 Flunarizine dihydrochloride 100 mg

Y0000265 Flunarizine dihydrochloride – reference spectrum n/a

Y0000266 Flunarizine dihydrochloride for system suitability 20 mg

F0190000 Flunitrazepam – * psy 100 mg

Y0000169 Flunitrazepam – reference spectrum n/a

Y0000443 Flunixin meglumine 10 mg

Y0000444 Flunixin impurity B 10 mg

Y0000445 Flunixin impurity C 50 mg

F0200000 Fluocinolone acetonide 100 mg

F0230000 Fluocortolone pivalate 100 mg

Y0000796 Fluorescein 120 mg

Y0000804 Fluorescein impurity C 0.01 mg

Y0000454 Diacetylfluorescein 100 mg

F0245000 Fluoresceine sodium – reference spectrum n/a

F0250000 Fluorouracil 50 mg

Y0000762 Fluorouracil impurity A 10 mg

Y0000763 Fluorouracil impurity B 10 mg

Y0000764 Fluorouracil impurity C 10 mg

Y0000765 Fluorouracil impurity F 10 mg

Y0000791 Fluorouracil impurity mixture 0.0002 mg

F0253000 Fluoxetine hydrochloride 250 mg

F0253020 Fluoxetine impurity B (methyl(3-phenylpropyl)amine) 5 mg

F0253030 Fluoxetine impurity C 5 mg

Y0000064 Flupentixol dihydrochloride 100 mg

Y0000067 Flupentixol impurity D 15 mg

Y0000078 Flupentixol impurity F 25 mg

F0260000 Fluphenazine decanoate 60 mg

Y0000009 Fluphenazine enantate 100 mg

F0280000 Fluphenazine dihydrochloride 50 mg

Y0000708 Fluphenazine impurity mixture 0.07 mg

Y0000298 Fluphenazine octanoate 10 mg

Y0000299 Fluphenazine sulphoxide 10 mg

Y0000211 Flurazepam monohydrochloride – reference spectrum n/a

F0285200 Flurbiprofen 50 mg

F0285202 Flurbiprofen impurity A 20 mg

Y0000236 Fluspirilene 20 mg

Y0000375 Fluspirilene impurity C 10 mg

F0285600 Flutamide 50 mg

F0285603 Flutamide impurity C 20 mg

Y0000284 Fluticasone propionate 100 mg

Y0000221 Fluticasone impurity D 10 mg

F0290000 Flutrimazole 100 mg

F0290010 Flutrimazole impurity B 60 mg