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.
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