欧洲药典 新版“凡例”发布！拟取消“注射用水”、“纯化水”标准中无机物等化学测试！
近日，欧洲药典EDQM发布两则更新公告，包括关于欧洲药典凡例修订通过及拟修订注射用水标准的公告，如下：
chapter 1. General Notices
凡例
At its 169th session (March 2021), the European Pharmacopoeia(Ph. Eur.) Commission adopted a revised version of chapter 1. General Notices.
欧洲药典(Ph. Eur.)委员会在其第169次会议 (2021年3月)通过了修订后的凡例。
Overhauled to provide greater clarity for users, the structureand content of the chapter have also been reviewed.
为了给用户提供更清晰的信息，本章的结构和内容也经过了审查。
The chapter features new additions such as a section onmonographs for medicinal products containing chemically defined activesubstances (reproducing the paragraphs on dissolution and disintegration asadopted by the Ph. Eur. Commission in November 2020 – see news of 10 December 2020).This new section also provides information on related substances and impuritiestaken from the relevant Technical Guide (Technical Guide for the elaborationof monographs on medicinal products containing chemically defined active substances [2020]).
增加了新的内容，如含有明确化学活性物质的药品的各论章节(复制了EP委员会于2020年11月通过的溶出度和崩解度段落---参见2020年12月10日新闻)。本节还提供了相关物质和杂质的信息，摘自相关技术指南(关于含明确化学活性物质的药品各论的细化技术指南[2020])。
The wording and terminology have been further harmonised andclarified. For example, synonyms have been weeded out, with “medicinal product”selected over the formerly interchangeable “finished product” and“pharmaceutical preparation”.
措辞和术语已进一步协调和澄清。例如，同义词已经被淘汰，以前可相互替换的“成品”（finished product）和“药物制剂”（pharmaceutical preparation），一律使用“药品”（medicinal product）替代。
Further terminological changes include “shelf life” and “re-testperiod” instead of “period of validity” and “period of use”, in accordance withthe ICH guidelines. Definitions have also been added for “freshly preparedsolution” and “immediately before use”.
其他术语变更包括根据ICH指南使用“货架期”（shelf life）和“复验期”（re-test period），取代“有效期”（period of validity）和“使用期限”（period of use）。还增加了“新配制溶液”（freshly prepared solution）和“临用”（immediately before use）的定义。
Another addition is a sub-section on “Demonstration ofsuitability of monographs” that provides useful guidance for users.
另一个新增的部分是“各论适用性证明”，它为用户提供了有用的指导。
The scope of first and second identification series and ofalternative identifications described in monographs have been clarified andseveral changes, including an explanation of the rounding rule, information onchiral substances and an example of equivalents, have been introduced in thetests and assay sections of the General Notices.
对各论中所述的【第一鉴别】和【第二鉴别】的范围和【替代鉴别】范围进行了澄清，修订后的凡例还在【检查】和【含量】章节中做了几处修改，包括数字修约规则的解释、手性物质的信息和等同性举例。
Lastly, all the paragraphs concerning monographs on herbal drugsthat were previously dispersed throughout the text are now gathered together ina single section, for enhanced readability.
最后，原来分散在各处的所有关于植物药各论的段落，现在都归整到了一个单独的章节，以提高可读性。
The revised chapter will be published in Ph. Eur. Supplement10.7, available in October 2021.
修订后的凡例将在EP增补10.7中发布，自2021年10月开始可以获得。
Water For Injections
注射用水专论
Deletion of tests for inorganic substances in the section onsterilised water for injections (SWFI).3
删除无菌注射用水(SWFI)部分中的无机物测试。
This section currentlyincludes tests for Acidity or alkalinity, Chlorides, Nitrates, Sulfates,Aluminium, Ammonium, and Calcium and magnesium. It also describes aConductivity test, with specific acceptance criteria, depending on the size ofthe container.4
包括酸度或碱度、氯化物、硝酸盐、硫酸盐、铝、铵、钙和镁的测试。它还描述了电导率测试，根据容器的大小有特定的接受标准。
During discussion with otherpharmacopoeias in the context of international harmonisation, scientificevidence has been provided demonstrating that if a sample meets theconductivity requirements, it would also comply with the tests for inorganicsubstances listed above.5
在与其他药典就国际协调进行讨论时，提供了科学证据表明，如果样品符合电导率要求，那么它也将符合上述无机物的测试。
Based on well-known chemicaland physical properties of water, and ions in water, it is possible todetermine the minimum conductivity that these inorganic impurities wouldproduce when present at the highest allowable concentration for each of thespecies according to the chemical tests.6
根据众所周知的水和水中离子的化学和物理性质，可以根据化学测试确定这些无机杂质在每种物质的最高允许浓度时产生的最低电导率。
Consequently, if the samplepassed the conductivity test, it would necessarily pass each of the originalchemical tests. In view of the above, the chemical tests could be deleted infavour of a single, instrument-based, quantitative test.7
因此，如果样品通过了电导率测试，就必定可以通过每一个原始的化学测试。鉴于上述情况，可以删除化学测试，而采用单一的、基于仪器的定量测试。
It is therefore proposed todelete the tests for Acidity or Alkalinity, Chlorides, Nitrates, Sulfates,Ammonium, and Calcium and magnesium. The test for Aluminium, however, will bemaintained, since it is a requirement for SWFI used in the manufacture of dialysissolutions.8
因此，建议取消酸度或碱度、氯化物、硝酸盐、硫酸盐、铵以及钙和镁的测试。然而，铝的测试将被保留，因为它是用于透析溶液制备的SWFI（无菌注射用水）的要求。
The possibility of revising these aspectsin the monograph Purified water (0008) is under consideration.
当前，正在考虑修订专论《纯化水》(0008)中这些方面的可能性。
