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The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has announced, in a July 1, 2020 press release, the publication of a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.
General chapter 2.6.32 Test for Bacterial Endotoxins Using Recombinant Factor C describes a test for bacterial endotoxins, which may be used as an alternative to classic limulus amoebocyte lysate (LAL)-based methods. The test described in the new chapter utilizes a recombinant factor C (rFC) based on the gene sequence of the horseshoe crab and fluorimetric detection, in accordance with other kits that are available on the European market.
Through the introduction of the new chapter, Ph. Eur. users will have the option of using a standardized method, which will be official in the 39 countries that are signatories to the Ph. Eur. convention. The rFC test can be used in the same way as LAL-based methods, once its fitness for use for the specific substance or product has been demonstrated. Validation of the rFC for BET testing will not be required; however, replacing a LAL-based method prescribed in a monograph by an rFC-based method is considered to be the use of an alternative method, as described in the Ph. Eur. general notices.
“When used under appropriate conditions, rFC-based methods provide the same guarantee of a product’s compliance with the test for bacterial endotoxins-and therefore, of its safety for use in patients-as LAL-based methods,” said Susanne Keitel, EDQM’s director, in the press release.
Additionally, the revised chapter 5.1.10 Guidelines for Using the Test for Bacterial Endotoxins has been published in the supplement. Revisions to the chapter now reflect the status of rFC-based methods and provides prerequisites for their use.