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。根据标准物质的用途(如鉴别、纯度检查、含量测定),可能会作为国际协作研究的项目。根据ISO导则34基本原则建立与分发标准物质。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。
EDQM被指定为WHO抗生素国际标准品的协作标定中心
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抗生素国际标准品(ISA)协作标定与分发中心。EDQM负责抗生素国际标准品的制备、贮藏与分发。WHO抗生素国际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。
Order Code Reference Substance Quantity per vial
Y0000894 Nilutamide impurity B 5 mg
Y0000055 Acamprosate calcium - reference spectrum n/a
Y0000116 Acamprosate impurity A 50 mg
Y0000500 Acarbose 94.7 mg
Y0000354 Acarbose for identification 10 mg
Y0000427 Acarbose for peak identification 40 mg
A0040000 Acebutolol hydrochloride 50 mg
Y0000359 Acebutolol impurity B 10 mg
Y0000127 Acebutolol impurity C 20 mg
Y0000128 Acebutolol impurity I 0.004 mg
Y0000056 Aceclofenac - reference spectrum n/a
Y0000085 Aceclofenac impurity F 20 mg
Y0000086 Aceclofenac impurity H 10 mg
Y0000810 Acemetacin 100 mg
Y0000811 Acemetacin impurity A 10 mg
A0050000 Acenocoumarol 20 mg
A0070000 Acesulfame potassium 50 mg
A0070020 Acesulfame potassium impurity B 10 mg
A0100000 Acetazolamide 100 mg
Y0000002 Acetylcholine chloride 50 mg
A0150000 Acetylcysteine 50 mg
A0152000 Acetylcysteine impurity C 10 mg
A0153000 Acetylcysteine impurity D 10 mg
Y0000565 ?-Acetyldigoxin 30 mg
Y0000642 ?-Acetyldigoxin for peak identification 10 mg
A0200000 Acetylsalicylic acid 100 mg
A0208000 N-Acetyltryptophan 125 mg
A0202000 N-Acetyltyrosine 200 mg
Y0000693 Acholeplasma laidlawii BRP 1 ml
A0220000 Aciclovir 75 mg
A0221000 Aciclovir impurity A 15 mg
A0225000 Acitretin 100 mg
Y0000360 Acriflavinium monochloride 1 mg
A0230000 Adenine 50 mg
A0230200 Adenosine 50 mg
Y0000110 Adipic acid 50 mg
Y0000882 Adrenaline 5 mg
A0300000 Adrenaline tartrate 200 mg
Y0000740 Adrenaline impurity mixture 0.005 mg
Y0000707 Adrenaline tartrate with impurity A 15 mg
Y0000728 Agnus castus fruit standardised dry extract 200 mg
A0325000 Alanine 50 mg
A0325100 Albendazole 50 mg
A0325200 Alcuronium chloride 50 mg
A0325450 Alfacalcidol 5 mg
A0325451 Alfacalcidol - reference spectrum n/a
A1225000 Alfadex 150 mg
A0325500 Alfentanil hydrochloride - reference spectrum n/a
A0325800 Alfuzosin hydrochloride 50 mg
A0325801 Alfuzosin impurity A 10 mg
Y0000832 Alfuzosin for system suitability 10 mg
A0349000 Allantoin 60 mg
A0350000 Allopurinol 50 mg
A0350010 Allopurinol impurity A 10 mg
A0350020 Allopurinol impurity B 10 mg
A0350030 Allopurinol impurity C 10 mg
A0350040 Allopurinol impurity D 10 mg
A0350050 Allopurinol impurity E 20 mg
A0351000 Allylstrychnine bromide 10 mg
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欧洲药典标准品