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| EDQM標準物質藥品質量管理局的歐洲藥典標準品 | |||
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歐洲藥典》為歐洲藥品質量檢測的惟一指導文獻。所有藥品和藥用底物的生產廠家在歐洲范圍內推銷和使用的過程中，必須遵循《歐洲藥典》的質量標準。
《歐洲藥典》由歐洲藥品質量管理局（EDQM）負責出版和發行，歐洲藥典委員會1964年成立。
EP可提供1900多個參考標準品，歐洲藥典個論規定并正式有效，包含化學物質、生物制品和對照圖譜。
歐洲藥典標準品質量和可靠性的保證，EDQM實驗室按EP個論規定方法選擇和檢查參考標準品批號及其制備, 其官方報告由歐洲藥典委員會批準。
需注意，歐洲藥典標準品由于已通過歐洲藥品委員會認證，故標準品不隨帶證書（見《歐洲藥典關于標準品證書的聲明》），純度和有效期見以下介紹。購買歐洲標準品在中藥標準對照品研究中心聯系客服就可以買的到
歐洲藥典關于純度和有效期的說明：
關于有純度：一般可作為100％使用，詳見以下描述。
TOPICS : 03- Ph.Eur. REFERENCE STANDARDS (CRS/BRP) / 01- General / 05. How can I find out the assay/content of a CRS?
You can obtain it from our catalogue of reference standards, which is available at http://CRS.edqm.eu. If the content is not required to perform the test(s) described in the Ph.Eur. monograph (see also the FAQ about "What is the intended use of CRS/BRP?"), it is not indicated in the catalogue or on the label (or on the leaflet) and you cannot assume the content of a CRS to be 100% for a quantitative test.
However, when an impurity reference standard is used in a related substances test for the control of impurity, if no assigned content is stated on the label, the purity of the reference standard, for the purpose of this estimation, is considered to be 100 per cent.
關于有效期：
TOPICS : 03- Ph.Eur. REFERENCE STANDARDS (CRS/BRP) / 01- General / 04. How do we find out the Expiry date of CRS/BRP?
No expiry date is indicated as European Pharmacopoeia Reference Standards are monitored regularly. It is down to the user to demonstrate that the CRS/BRP used in an official Ph. Eur. test or assay was current at the time of use. The “information” column of the catalogue may indicate an official date on which the batch is no longer valid as a CRS/BRP. Therefore, it is recommended to purchase only a sufficient amount for immediate need and to use the products as soon as possible. Moreover, the stability of the contents of opened vials or ampoules cannot be guaranteed.
Y0000055 Acamprosate calcium - reference spectrum n/a
Y0000116 Acamprosate impurity A 50 mg
Y0000500 Acarbose 100.1 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
A0050000 Acenocoumarol 20 mg
A0070000 Acesulfame potassium 50 mg
A0070020 Acesulfame potassium impurity B 10 mg |
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