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欧洲药典第十版来袭,将于 2020 年 1 月 1 日实施

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发表于 2019-7-12 10:20:57 | 显示全部楼层 |阅读模式
欧洲药典第十版来袭,将于 2020 年 1 月 1 日实施
本文来自 gmp-compliance 和 EDQM 官网



The 10th Edition of the Ph. Eur. consists of new texts (amongst others, 5.25. Process Analytical Technology, PAT) as well as all current texts from the 9th Edition, some of which have been revised or corrected.
欧洲药典第十版(EP 10.0)包括新文本(其中 5.25, 过程分析技术(PAT),以及当前第 9 版的所有内容,其中一些已被修订或更正。


As of the 10th Edition of the Ph. Eur.,
EP 10.0 内容:
revised and / or corrected parts of texts are indicated by vertical lines (print version),
文本的修订和/或更正已用竖线标出(纸质版)

horizontal lines indicate where parts of texts have been deleted (print version),
划线表示文本已被删除(纸质版)

a QR Code is included at the start of each text, providing a link to further information (e.g. the Knowledge database),
每篇的开头都有二维码,为更多的信息提供超链接(如知识库)

the wording used in the calculation of percentage contents in tests for related substances has been modified to specify the full name of the substance (i.e. including counter-ions, hydrates etc.),
修订了有关物质中计算百分含量的措辞,明确该物质的全称(如反离子、水合物等),

tests using diphosphorus pentoxide, mainly tests for loss on drying, have been modified to avoid the use of this substance due to its toxicity,
因为五氧化二磷的毒性,对需使用五氧化二磷的测试进行了修订,主要是干燥失重测试

the names and descriptions of the reagents used to describe stationary GC phases have been revised,
修订了气相色谱固定相的试剂的名称和描述

‘Tamper-proof ’ has been replaced by ‘tamper-evident’,
‘Tamper-proof ’改为‘tamper-evident’,

reference to general chapter 2.8.23. Microscopic examination of herbal drugs has been added when microscopic examination is carried out using a powder with a non-standard sieve size,
通则第 2.8.23《植物药的显微镜检查》:当使用非标准尺寸的筛网进行显微镜检查粉末时,增加了参考文献

the terms ‘coarse’ and ‘coarsely’ have been deleted from ‘coarse powder’ and ‘coarsely powdered herbal drug’ (2.9.12. Sieve test),
“粗”和“粗的”两词已从“粗粉”和“植物药粗粉”中删除(2.9.12 筛分试验),

results are expressed in percent instead of percent m/m in the tests 2.8.16 Dry residue of extracts and 2.8.17 Loss on drying of extracts.
在<2.8.16 萃取物干燥残渣>和<2.8.17 萃取物干燥损失>的测试中,结果用百分比表示,而不是用百分数 m/m。


新增部分
The following texts appear for the first time in the European Pharmacopoeia. They will be implemented on 1 January 2020 at the latest.
EP 10.0 新增以下章节,最迟于 2020 年 1 月 1 日生效!

2.6.35. Quantification and characterisation of residual host-cell DNA
残留宿主细胞 DNA 的定量和表征

2.9.49. Powder flow properties by shear cell methods
粉末流动性(剪切细胞法)

2.9.52. Scanning electron microscopy
扫描电子显微镜法

3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes
用于人体血液制品和血液成分的容器及其生产过程中中使用的材料;输血套及其生产物料;预灌封注射器

5.25. Process analytical technology
过程分析技术






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