Friday, 10 July 2015

Pharmeuropa 27.2

A new edition of Pharmeuropa has been published. Pharmeuropa is a free online EDQM publication. Draft monographs are published in Pharmeuropa for public enquiry.

Of interest in the edition are:

2.4.8    Deletion of the test for heavy metals

A list of the texts impacted by the deletion of the test for heavy metals (2.4.8) is published for public consultation. Due to the large number of texts, deletion of the test from individual monographs will be implemented in the 9th Edition (9.0) of the European Pharmacopoeia (1 January 2017).

Water for injections (0169)

A revision of the monograph is proposed to take into account current manufacturing practices using methods other than distillation for producing water of injectable quality. The monograph revision is supported by the evidence provided in the document Reverse osmosis in Ph. Eur. monograph Water for injections (0169), published in Pharmeuropa (Useful information).

Substances for pharmaceutical use (2034)

Related substances and Bacterial endotoxin sections have been revised.

Posted by Tim Sandle