Heparin Impurity Screening

Impurities testing in Heparin APIs to GMP and GLP Compliant Standards

Intertek provides GMP compliant screening of specified impurities in heparin active pharmaceutical ingredients (API) by 1H NMR and capillary electrophoresis (CE).

The heparin analytical techniques, carried out to FDA recommendations, can rapidly and effectively screen for the presence of a specific impurity highlighted as a safety concern by the FDA. It is recommended that both screening techniques be used for heparin API prior to batch release but can also be used for finished product Quality Control (QC) applications. The NMR technique employs a 500 MHz instrument and these services are available via Intertek’s GMP Pharmaceutical Laboratories.

Request more information to see how Intertek can help your organization with Heparin Impurity Screening.