The European Pharmacopoeia (Ph. Eur.) Commission has officially adopted general chapter 2.6.32 Test for Bacterial Endotoxins using Recombinant Factor C!
The EDQM (European Directorate for the Quality of Medicines) announced this in a
press release on 11 December 2019. After releasing a draft text for comment in November 2018, the European Pharamacopoeia is now taking the next step to make endotoxin testing with recombinant Factor C (rFC) a compendial method in Europe. This is exciting news for users of Lonza’s
PyroGeneTM recombinant Factor C assay, as it will allow customers to use rFC without the necessity for an alternative method validation. The new chapter 2.6.32 is announced to be published on 01 July 2020 in Ph.Eur. supplement 10.3 and will be effective as of 01 January 2021. As per
EDQM’s FAQ, authorities usually accept practical application of a text after the publication date, prior to the implementation date.
We’ll keep you updated with more information as it becomes available!
Written by Saskia
Scientific Support Specialist, Lonza Pharma-Bioscience Solutions at Lonza
