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Heparin impurity screening and analysis available in accordance with Good Manufacturing Practice (GMP) or Good Laboratory Practice (GLP) to USP standards
There have been instances of contaminant observed in heparin pharmaceutical products and some medical devices, such as certain catheters. To ensure the safety of heparin-containing products it is important to test the heparin active pharmaceutical ingredient (API) in these products.
Our scientists provide GMP compliant screening of specified impurities in heparin active pharmaceutical ingredients for heparin suppliers and manufacturers by applying 1H nuclear magnetic resonance (NMR) spectroscopy and Liquid Chromatography (LC), providing a more robust and thorough approach in accordance with contemporary standards.
Intertek’s heparin analytical techniques, carried out to US FDA recommendations – Stage 1 and Stage 2 methodology - can rapidly and effectively screen for the presence of specific impurities which have been highlighted as a safety concern by the FDA and consequently revised by USP. We are capable of identifying sections A, B and C of the Heparin Monograph Stage 2.
It is recommended that both screening techniques be used for the heparin API prior to batch release. These analytical approaches can also be used for GMP compliant finished product quality control (QC) applications. Contact our experts for specific requirements, including testing via CE (Capillary electrophoresis) at one of our GMP pharmaceutical laboratories.
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