Navigation Links
QualTech Laboratories Validates USP Protocols for Anti-Factor IIa Chromogenic Assay for Potency
Date:8/12/2009

OCEAN, N.J., Aug. 12 /PRNewswire/ -- 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."

About QualTech Laboratories, Inc.

QualTech Laboratories, Inc., founded in 1996, specializes in biological assays, toxicity studies, and quality control measures, including menotropins assays (FSH and LH), heparin studies, anti-factor Xa activity testing, anti-factor IIa assays, and bacterial endotoxins testing. QualTech works with USP (United States Pharmacopeia), EP (European Pharmacopoeia), and BP (British Pharmacopoeia) methods and provides all supporting tests for those monographs.

More information about QualTech Laboratories, Inc. is available online at www.QualTechLabsInc.com, by telephone at (732) 918-0207, and via email at eraike@qualtechlabsinc.com.


'/>"/>
SOURCE QualTech Laboratories, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Daiichi Sankyo and Forest Laboratories Finalize Contract for Co-Promotion of AZOR(TM)
2. Forest Laboratories, Inc. and Gedeon Richter Announce Results of Phase II-B Study for RGH-188 as a Treatment for Schizophrenia
3. Forest Laboratories, Inc. Announces Positive Results of LEXAPRO(R) Phase III Study in Adolescents With Major Depression
4. Romark Laboratories Raises $18 Million in Institutional Financing
5. Microbia and Forest Laboratories Announce Preliminary Results of Linaclotide Phase 2b Studies
6. Romark Laboratories Initiates Phase II Study of Nitazoxanide in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1
7. Northfield Laboratories Inc. Presentation at FDA/NIH Workshop on Hemoglobin-Based Oxygen Carriers
8. Ironwood Pharmaceuticals and Forest Laboratories Announce Presentation of Linaclotide Phase 2b Chronic Constipation Study Results
9. Romark Laboratories Completes Enrollment in U.S. Phase II Study of Nitazoxanide for Chronic Hepatitis C Genotype 1 Non-Responders
10. Forest Laboratories Announces Positive Results from Phase III Clinical Studies of Ceftaroline for the Treatment of Complicated Skin and Skin Structure Infections
11. Forest Laboratories, Inc. and Gedeon Richter Plc Announce Positive Phase II Results with the Investigational Antipsychotic Cariprazine in Patients with Acute Mania Associated with Bipolar I Disorder
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... YORK , May 25, 2016 ... Market Size, Share, Development, Growth and Demand Forecast to ... Syringe, Insulin Pump and Others)" published by P&S Market ... at $9,998.3 million in 2015, and it is expected ... Based on type, the insulin pump segment is expected ...
(Date:5/25/2016)... Inivata, a global clinical ... tumour DNA (ctDNA) analysis to improve personalised healthcare ... Clive Morris as Chief Medical Officer. ... development programme, scientific collaborations, and through to commercialisation ... in clinical outcomes for patients. Clive ...
(Date:5/24/2016)...   , Study met ... and superiority in , Excellent plus ... of the ascending colon   , ... B.V. today announced new positive data from the phase III MORA ... standard 2 litre PEG with ascorbate. The study met both primary ...
Breaking Medicine Technology:
(Date:5/26/2016)... Georgia (PRWEB) , ... May 26, 2016 , ... ... certificate in intellectual property (IP) to its specialty academic programs. , Answering to ... the college’s existing certificate programs in health law, and environmental and land use ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... a significant negative impact on long-term patient survival, reports a team of UPMC ... online this week in the Journal of Thoracic and Cardiovascular Surgery, provide critical ...
(Date:5/26/2016)... ... May 26, 2016 , ... Dr. James Maisel will present ... Island Chapter on June 4, 2016, 1:30-3:30 pm at the Farmingdale Public Library. ... Retina Group of New York , is a Board Certified ophthalmologist who completed ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... supply chain solutions, today announced the organization has earned its ISO 13485 certification, ... and is compliant with all rules and policies associated with ISO quality standard ...
(Date:5/26/2016)... ... 26, 2016 , ... Nike Yoga Camps at East West ... arts & crafts, discussions, and games all geared towards enhancing your child’s physical ... backgrounds in kids’ yoga, collegiate sport yoga instruction, and global yoga training. Nike ...
Breaking Medicine News(10 mins):