Heparin Potency Testing
Project Description
Pharmaceutical Bioanalytical Laboratory needed for potency testing on heparin-by-products, also named heparinoids. Test methods: both USPXIX clotting assay, as described for Heparin Sodium and Ph.Eur. 8.0 ed. as described in chapter 2.7.5.
Reference standard: current USP ref. standard Heparin sodium for assay
No validation required for the performance of the tests on the heparin-by-product substances.
Project Information
Number:19-01044
Industry:Biologics