Pharmeuropa 25.2

A new edition of Pharmeuropa: 25.2, has recently been published. This is the forum where draft European Pharmacopeia monographs are published for public comment.

If no further revision is required the draft monograph is proposed to the European Pharmacopoeia Commission if adopted an implementation date is given and this is about one year after the adoption of the monograph. The monograph is then published in the European Pharmacopoeia (or supplement). The monograph is published about 6 months after adoption. Therefore draft text appearing in Pharmeuropa may not become official for up to 2 years. Those monograph’s adopted will be highlighted in reviews of the European Pharmacopoeia or supplements.

In the new edition, there is one change of interest:

Monograph 3.2.1.        Glass Containers for Pharmaceutical Use

The main changes are:

Production: a section has been introduced to address the risk related to potential delamination of glass containers. This is done by raising awareness of the pharmaceutical manufacturers of the factors contributing to the phenomenon which resulted in a number of recalls. Although only a very small number of containers was affected it is an important factor to be considered for both the glass manufacturers and the pharmaceutical users.

Harmonisation with ISO 4802 – 1 and 4802 - 2: adjustment was made to avoid ambiguities with ISO. This includes the addition of an additional volume specification for containers of a volume of 2 to 3 mL in Table 3.2.1-3 and Table 3.2.1-7.

Test for surface hydrolytic resistance – determination by flame spectrometry: some editorial modifications were made to clarify the text.

Hydrolytic resistance of glass grains: alternative grinding device introduced to include state of the art equipment resulting in increased reproducibility of sample preparation.

Need for control of specific components that may be toxic for chronic use and vulnerable patient groups: this information was already proposed in a previous publication in Pharmeuropa 24.2

For further details, see EDQM.

Posted by Tim Sandle