The European Pharmacopoeia has revised chapter 3.2.1. “Glass containers for pharmaceutical use”.
The revision was issued to clarify the purpose of tests A, B, and C used to define the type of glass and characterize the hydrolytic resistance of the glass. The presentation of the information (Table 3.2.1-1) has been modified to add further details about each test and its respective purpose.
The second update concerns the approach used to determine the maximum transmission limit for colored glass containers. Since the light protection or light transmission of a coloured glass depends on the wall thickness of the containers, it was decided to base the determination of the maximum spectral transmission and related specifications on the wall thickness insteadof the volume and closure system of the containers. The proposed limits take into account detailed data on containers available on the European market.
SOURCES: