OCEAN, NJ, August 12, 2009 — QualTech Laboratories, Inc., an analytical testing laboratory specializing in biological assays, toxicity studies, and quality control measures, announced today that they have validated the USP (United States Pharmacopeia) method for the anti-factor IIa chromogenic assay for potency. This anti-factor IIa assay is a required component of the newly-revised Heparin Sodium monograph, which becomes effective October 1, 2009.
The Heparin Sodium monograph was revised due to previous contamination which resulted in multiple fatalities. The revisions to the Heparin Sodium monograph improve purity, potency, and identity tests. Among these revisions, the anti-factor IIa assay for potency replaces the previously-used sheep plasma-based clotting assay.
In anticipation of the changes to the Heparin Sodium monograph, QualTech Laboratories began testing the new anti-factor IIa assay protocols in early 2009, and validated the method in March of 2009. Elizabeth Raike, President and CEO of QualTech Laboratories, affirms, “We have validated the anti-factor IIa chromogenic assay according to USP <1225> Validation of Compendial Procedures for accuracy, precision, specificity, linearity, and range. We wanted to be proactive in validating the anti-factor IIa assay so that we could help companies smoothly transition to the requirements of the revised USP Heparin Sodium monograph.”
QualTech Laboratories has been performing the anti-factor IIa assay for years according to both EP (European Pharmacopoeia) and BP (British Pharmacopoeia) methods, and therefore offers a wealth of experience to pharmaceutical firms. Additionally, the anti-factor Xa activity test, which is also part of the Heparin Sodium monograph, has been one of QualTech Laboratories’ specialties for over 10 years.
“The revisions to the Heparin Sodium monograph were approved very swiftly,” Raike notes. “This could cause drug companies significant pressure in their efforts to keep Heparin Sodium on the market. With our validated anti-factor IIa assay method, they don’t have to miss a beat – we can keep their drugs in the marketplace and generating revenue.”