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 for heparin testing include chromogenic assays of anti-factor IIa and anti-factor Xa activities. USP monograph for heparin sodium had been previously updated.

We have implemented and validated these challenging assays according to USP monograph and are ready to be used for drug product and drug substance. However, personalized method adjustments are necessary in 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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