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Issue no. 19, Sep. 21, 2021

FROM THE LAB

The USP Heparin Monograph

Heparin by definition is an injectable anticoagulant that decrease blood clots and help in preventing harmful clots damage in blood vessels. Heparin is also known to bind to various proteins and modulates their activity which includes decreasing inflammation.


Heparin and Enoxaparin

Heparin is a high molecular weight highly sulfated negatively charged linear anionic carbohydrate polymer belonging to a chemical class glycosaminoglycans (GAGs). Several types of Low Molecular Weight Heparins (LMWH) are obtained by conversion from high molecular weight heparin employing various different methods. Enoxaparin is the most commonly used LMWH in the United States. It gives very predictable anticoagulant response. Heparin and Enoxaparin are offered by several pharmaceutical companies. Many compounding pharmacies (503A & 503B) package Heparin in user friendly bags in defined concentrations.


ARL-Eutech's role in Heparin testing

ARL-EuTech has been performing Potency Assays, method verifications and stability testing for heparin formulations for various companies. ARL-Eutech is one of the few contract laboratories in the country capable of performing the entire USP Heparin monograph, including:

  • Chromatographic Identity
  • Anti-Factor Xa to Anti-Factor IIa Ratio
  • Molecular Weight Determination
  • Potency Assay
  • Nucleotidic Impurities
  • Protein Impurities
  • Stability
  • Loss on Drying
  • Limit of Galactosamine in Total Hexosamine
  • Absence of Oversulfated Chondroitin Sulfate
  • Heavy Metals
  • Other customized testing

ARL-EuTech has done complete chemical characterization of Enoxaparin for several different pharmaceutical customers, and each time, the complete data package was submitted to the FDA.

The laboratory is DEA-certified for Schedules I through V controlled substances, and is registered with the FDA, strictly following GLP/GMP guidelines.

Please visit ARL-Eutech at www.eutechsci.com for further information, and contact us at custserv@eutechsci.com for immediate assistance.

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