近日，EDQM发布了新的《欧洲药典》 3.2.1 药用玻璃通则（草案），这是自 2019 年在增补本 9.6 发布后，迎来首次重大修订。此次修订聚焦回应疑问与技术改进，其成果已发布并公开征求意见，有望进一步完善玻璃相关检测标准与规范。
以下原文及其翻译：
Thanks to the efforts and dedication of the experts of the Glass (GLS) Working Party, general chapter 3.2.1 has undergone its first significant revision since 2019, when it was published in European Pharmacopoeia (Ph. Eur.) Supplement 9.6.
The primary aim of this revision is to clarify the purpose of tests A, B and C used to define the glass type and characterise its hydrolytic resistance, in response to multiple questions received from users concerning this part of the text. Additional details on each test and its purpose have therefore been incorporated and the presentation of the information has been changed.
The second key update in this general chapter is the modernisation of the spectral transmission test for coloured glass containers. As the light protection or light transmission of a coloured glass depends on the wall thickness of the containers, it was decided to modify the approach used to determine the maximum transmission. As a result, the determination and corresponding specifications are now based on the wall thickness instead of the volume and closure system of the containers. The proposed limits are based on those presented in the version of this general chapter published in Supplement 9.6 of the Ph. Eur. and take into account extensive data for containers on the European market.
The revised general chapter has now been published in Pharmeuropa 37.3, where it will remain open for public consultation until the end of September 2025. All interested parties are encouraged to review it and submit their comments.
For more information on how to comment, please consult our “How to comment” guide. Comments from states parties to the European Pharmacopoeia Convention should be sent to the responsible national pharmacopoeia authority (NPA); comments from other countries or from industry associations should be sent to the European Directorate for the Quality of Medicines & HealthCare (EDQM) via the EDQM HelpDesk.
由于（GLS） 工作组专家的努力和奉献精神，通则 3.2.1 自 2019 年在欧洲药典 （Ph. Eur.） 上发布以来进行了首次重大修订。增补 9.6.
此次修订的主要目的是澄清用于定义玻璃类型和表征其耐水解性的测试 A、B 和 C 的目的，以回答用户收到的有关这部分文本的多个问题。因此，有关每项测试及其目的的额外细节已被纳入其中，并且信息的呈现方式也已更改。
本通章的第二个关键更新是彩色玻璃容器光谱透射测试的现代化。由于彩色玻璃的遮光或透光率取决于容器的壁厚，因此决定修改用于确定最大透射率的方法。因此，确定和相应的规格现在基于容器的壁厚，而不是容器的体积和封闭系统。拟议的限制基于欧洲药典增刊 9.6 中发布的本通章版本中提出的限制，并考虑了欧洲市场上集装箱的大量数据。
修订后的总章现已在 Pharmeuropa 37.3 中发布，在 2025 年 9 月底之前将继续公开征求公众意见。我们鼓励所有感兴趣的各方对其进行审查并提交他们的评论。
有关如何评论的更多信息，请参阅我们的“如何评论”指南。《欧洲药典公约》缔约国的意见应发送给负责的国家药典机构 （NPA）;来自其他国家或行业协会的评论应通过EDQM服务台发送给欧洲药品与健康护理质量局（EDQM）。
