NMR-Analysis of Pharmaceuticals containing Heparin

LipoFIT is a certified testing laboratory officially notified to the competent authority and thus holding a statement of GMP compliance issued by the Regierung Oberbayern (ZLB) as an external testing laboratory for pharmaceuticals. LipoFit offers purity testing according to the respective authority's specifications using state of the art equipment and minimal sample processing time (typically less than 24 hours from receiving the sample).

LipoFIT offers the following NMR tests to its customers:

• heparinFIT: Purity testing of heparin according to the specifications of the BfArM
• heparinFIT-USP: Purity testing of heparin according to the specifications of the USP (US Pharmacopeia)
• NEW !!! heparinFIT-PE: Purity testing of heparin according to the latest monographs of the PhEur (European Pharmacopeia) effective from August, 1st, 2010 NEW !!!

Background informations:
Heparin is used as an anticoagulant, for instance, for the prevention and treatment of thrombosis. In 2008 several death cases under Heparin treatment have been reported in the US. In Europe dozens of cases of severe allergic reactions have been filed. These incidents happened due to the contamination of the Heparin products.

To prevent any possible dangers to patients, worldwide authorities as the Federal Institute for Drugs and Medical Devices (BfArM) and the US Food and Drug Administration (FDA) established official directives: All batches of pharmaceuticals containing Heparin must be tested for possible contaminations before any release in the market.

If you should be interested into LipoFIT'S tests, please contact us directly by

E-mail: christiane.proll@lipofit.de | Phone: +49 941 698091-04

Product brochure heparinFIT

NMR-tests for heparin purity testing

[Download]

Further Information

BfArM Announcement March, 14th 2008 (german)

[BfArM]

Protocol for testing of non-fractionated Heparin (german)

[Unfraktionierte Heparine]

Protocol for testing of fractionated Heparin (german)

[Fraktionierte Heparine]

Description of the NMR Method approved by BfArM

[NMR- Method]

© LipoFIT 2011