No expiry date is assigned to EDQM reference standards, but they are monitored regularly. Users must ensure that the EDQM reference standard is valid at the time of use by checking the batch validity statement (BVS) available from the Ph. Eur. reference standards database. We recommend that u...
模块④:Medicines医药 在该模块主要包括:European Pharmacopoeia(Ph. Eur.)欧洲药典、Biological Standardisation Programme(BSP)生物标准化计划、Reference Standards(RS)标准品或对照品、Certification of Suitability适用性证书、OMCL Network官方药品控制实验室网络、Anti-falsification activities防伪、Classification of medicines...
在该模块主要包括:European Pharmacopoeia(Ph. Eur.)欧洲药典、Biological Standardisation Programme(BSP)生物标准化计划、Reference Standards(RS)标准品或对照品、Certification of Suitability适用性证书、OMCL Network官方药品控制实验室网络、Anti-falsification activities防伪、Classification of medicines药物分类、Pharmaceutical...
Eur. monographs. You can find the list and the availability of these standards on the Ph. Eur. Reference Standards Database (downloadable). Please note that the catalogue is updated on a daily basis, so we recommend that you to use the online database instead of the downloaded version.EDQ...
reference standards database.标准物质附带的说明书(配合各论描述标准物质的正确使用时需要色谱图的情况下),可以从欧洲药典标准物质数据库中下载。2)In the Knowledge database, when available and especially when they may prove helpful for interpreting a monograph (e.g. for difficult separations).在知识数据...
其中,欧洲药典论坛可免费注册,用于查询“虽征求意见但未订入欧洲药典或既往的药典标准”等;而在Knowledge database知识数据库模块,可通过药物化学名称等,搜索欧洲官方对照品信息、已收载入药典标准的系统适用性色谱图及所用色谱柱具体品牌/厂家等,如下图所示: 2.2.2 Reference Standards(RS)标准品或对照品 在该模块...
2.2.2 Reference Standards(RS)标准品或对照品 在该模块,可以查询官方在售对照品信息(RS Online catalogue,也可在该模块查询色谱柱及谱图信息等)、下载对照品目录(RS Catalogue PDF);在“RS Store对照品商店”查询WHO抗生素标准品(ISA)和化学标准品(ICRS)信息,并可在线订购(当然,大多数药企是通过供应商采购的)。
(GDP) Dr Florence Benoit-Guyod © 2012 EDQM, Council of Europe, All rights reserved 8 GMP / GDP Inspectors Working Group: main activities relating to GMP – Discussions of EU Legislation – EudraGMP database – GMP for Medicinal Products (Part I, Annexures) – GMP for Active Substances...
EP标准品的购买方式和价格EDQM.pdf,55 June 2011 PHARMACEUTICALARDS STAND REFERENCE atalogue c Official Pharmacopoeia the European of BRP IR spectra, CRS, Members of the European Pharmacopoeia Commission: Austria, Belgium, Bosnia and Herzegovina, Bulgaria,
When required by the prescribed test and/or assay of the corresponding Ph. Eur. text, the content of a CRS is given in the leaflet available in the Ph. Eur. reference standards database. 当欧洲药典中规定的检测项目和/或含量测定需要某标准物质的标示含量时,此标准物质的标示含量可以在欧洲药典标...