Heparin Impurity Screening

Intertek provides GMP compliant screening of specified impurities in heparin active pharmaceutical ingredient (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 in February 2008. 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 500MHz instrument and these services are available via Intertek’s GMP Pharmaceutical Laboratories.

Pharmaceutical NMR Services from Intertek:

Intertek research laboratories provide advanced capability in nuclear magnetic resonance spectroscopy with NMR and LC-NMR analytical capabilities. State of the art instrumentation together with scientists experienced in the interpretation and the design of advanced experiments allows for a first rate contribution to trouble-shooting and complex scientific investigations.

The laboratory instruments are qualified to GLP and GMP/cGMP standards, allowing NMR data to be used in regulatory projects and pharmaceutical QC. The NMR Team also provide highly efficient routine services.

• Intertek ASG NMR Analysis
• GMP Pharmaceutical Laboratories
• Global Intertek NMR Analytical Capabilities
• FDA Recommendations for Heparin

• Heparin Verunreinigungen Screening