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.

See also:

• Direct link to the chapter: Direct link
• Pharmeuropa 37.3 just released