Wednesday, 9 October 2013

Updates to Phameuropa (European Pharmacopeia)

Pharmeuropa is an EDQM publication. Draft monographs are published in Pharmeuropa for public enquiry prior to publication in the European Pharmacopoeia (or supplement).

Items of interest are:

Pharmeuropa 25.3

5.1.2.   Reference Standards

General review and update to describe the current state of the art in pharmaceutical reference standards, including alignment with the specifications and definitions of the corresponding ISO Guides (e.g. ISO Guide 34:2009) and introduction of:

The definition of international standards based on WHO Technical Report Series 932,
Herbal reference standards (HRS),
Biological reference preparations (BRP) and chemical reference substances for biologicals.

Minor editorial changes have also been made throughout the text.

Pharmeuropa 25.4

2.7.18 Assay of Human Coagulation Factor II

It is proposed to remove EDTA from the dilution buffer because its presence has been reported to inhibit the ecarin-dependent coagulation factor II activation and cause a decrease in the sensitivity and precision of the assay.

Posted by Tim Sandle