【原创】欧洲药典标准品介绍

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2008/04/25

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分析化学

欧洲药典标准品介绍

可提供1900多个参考标准品

欧洲药典个论规定并正式有效：化学物质、生物制品和对照图谱。

新：可在线查阅参考标准品批号有效期说明(BVS)。这个工具便于用户保证上批标准品效期的可追踪性。新启用参考标准品清单也同时在线公布。

欧洲药典:质量和可靠性的保证

EDQM实验室按EP个论规定方法选择和检查参考标准品批号及其制备, 其官方报告由欧洲药典委员会批准。

网址：http://crs.edqm.eu/

需注意，欧洲药典标准品由于已通过欧洲药品委员会认证，故标准品不随带证书（见《欧洲药典关于标准品证书的声明》），纯度和有效期见以下介绍。

欧洲药典关于纯度和有效期的说明：

关于有纯度：一般可作为100％使用，详见以下描述。

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.

关于有效期：

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 The “information” column of the catalogue may indicate an official date on which the batch is no longer valid as a CRS/BRP.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.