Monday, 18 May 2015

European Pharmacopeia updates

Some updates of interest in relation to the European Pharmacopeia:

European Pharmacopoeia 8th Edition - Supplement 8.5 (implementation date 1st July 2015)

General Chapters

2.2.32  Loss on drying                                                                       

Clarification of the way instrument qualification is to be performed.

2.5.12  Water: semi-micro determination                                           

Clarification of the way instrument qualification is to be performed.

2.7.18  Assay of human coagulation factor II                                   

EDTA has been removed 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