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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.

歐洲藥典第十版（EP 10.0）包括新文本(其中5.25, 過程分析技術(shù)(PAT)，以及當(dāng)前第9版的所有內(nèi)容，其中一些已被修訂或更正。

As of the 10th Edition of the Ph. Eur.,

EP 10.0 內(nèi)容：

revised and / or corrected parts of texts are indicated by vertical lines (print version),

文本的修訂和/或更正已用豎線標(biāo)出(紙質(zhì)版)

horizontal lines indicate where parts of texts have been deleted (print version),

劃線表示文本已被刪除(紙質(zhì)版)

a QR Code is included at the start of each text, providing a link to further information (e.g. the Knowledge database),

每篇的開頭都有二維碼，為更多的信息提供超鏈接(如知識(shí)庫)

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.),

修訂了有關(guān)物質(zhì)中計(jì)算百分含量的措辭，明確該物質(zhì)的全稱(如反離子、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?yàn)槲逖趸椎亩拘?，?duì)需使用五氧化二磷的測(cè)試進(jìn)行了修訂，主要是干燥失重測(cè)試

the names and descriptions of the reagents used to describe stationary GC phases have been revised,

修訂了氣相色譜固定相的試劑的名稱和描述

‘Tamper-proof ’ has been replaced by ‘tamper-evident’,

‘Tamper-proof ’改為‘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,

通則第2.8.23《植物藥的顯微鏡檢查》：當(dāng)使用非標(biāo)準(zhǔn)尺寸的篩網(wǎng)進(jìn)行顯微鏡檢查粉末時(shí)，增加了參考文獻(xiàn)

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”兩詞已從“粗粉”和“植物藥粗粉”中刪除(2.9.12篩分試驗(yàn)),

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萃取物干燥殘?jiān)?gt;和<2.8.17萃取物干燥損失>的測(cè)試中，結(jié)果用百分比表示，而不是用百分?jǐn)?shù)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 新增以下章節(jié)，最遲于2020年1月1日生效！

2.6.35. Quantification and characterisation of residual host-cell DNA

殘留宿主細(xì)胞DNA的定量和表征

2.9.49. Powder flow properties by shear cell methods

粉末流動(dòng)性（剪切細(xì)胞法）

2.9.52. Scanning electron microscopy

掃描電子顯微鏡法

3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes

用于人體血液制品和血液成分的容器及其生產(chǎn)過程中中使用的材料；輸血套及其生產(chǎn)物料；預(yù)灌封注射器

5.25. Process analytical technology

過程分析技術(shù)

以上來自gmp-compliance和EDQM官網(wǎng)