Heparin & Polysaccharide Testing

Revised monographs in the European Pharmacopoeia on heparin sodium (0333) and heparin calcium (0332) are in force from January 1st, 2015. These monographs include chromogenic anti-factor IIa and anti-factor Xa assays. The USP monograph for heparin sodium had been updated previously.

We have implemented and validated these challenging assays according to the USP monograph and they are ready to be used for drug products and drug substances. However, personalized method adjustments are necessary on a case-by-case basis.

We have also developed several other assays for other glycosaminoglycans as chondroitin sulfate, heparan sulfate, dermatan sulfate and other heparinoids. Some of these methods are useful to check de quality of the raw products and to have a previous estimation of the purification process yield, depending of the scope of it.

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