Sunday, 11 December 2016

Pharmeuropa 28.4


A chapter of interest has been published in Pharmeuropa, and it is out for public comment. Draft monographs are published in Pharmeuropa for public enquiry, which lasts for three months. 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).

Draft Monographs and General Texts for Comment

3.2.1    Glass containers for pharmaceutical use

Hydrolytic resistance: additional details concerning the autoclaving process, with respect to equipment and handling, have been included; the procedure for cleaning the containers to be tested has been revised in order to result in better reproducibility.

Filling and heating: instructions have been added in order to cope with small containers in which the water is not sufficiently retained.

Posted by Dr. Tim Sandle