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
'/>"/>

SOURCE QualTech Laboratories, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

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:7/29/2014)... July 29, 2014  Cloud Pharmaceuticals, Inc., a ... development, announced today that it has been awarded ... Foundation Small Business Innovation Research (NSF SBIR) program. ... Cloud Pharmaceuticals designs new drugs and drug ... new, innovative cloud computing technology in place of ...
(Date:7/29/2014)... -- Encision Inc. (OTCQB:ECIA), a medical device company owning patented ... minimally invasive surgery, today announced financial results for its ... The Company posted quarterly net revenue of $2.476 ... or $(0.02) per share. These results compare to net ... $311 thousand, or $(0.04) per share, in the year-ago ...
(Date:7/29/2014)... July 29, 2014   ... that it has taken an exclusive worldwide licence to ... a Durham University spin-out company. ... pay an upfront fee, development and commercial milestone payments, ... also taken an option for additional exclusive licences to ...
Breaking Medicine Technology:Cloud Pharmaceuticals Receives Phase I NSF SBIR Grant Valued at $150,000 2Encision Reports First Quarter Fiscal Year 2015 Results 2Encision Reports First Quarter Fiscal Year 2015 Results 3Encision Reports First Quarter Fiscal Year 2015 Results 4Glide Pharma Takes Exclusive Worldwide Rights to Novel Diagnostic Technology for Prostate Cancer 2Glide Pharma Takes Exclusive Worldwide Rights to Novel Diagnostic Technology for Prostate Cancer 3
(Date:7/29/2014)... (PRWEB) July 29, 2014 Gummy smile ... and dark gums treatments that can enhance and perfect ... a balanced appearance that displays the teeth to their best ... gum tissue or have gums that are dark or discolored. ... to feel self-conscious about their smiles or experience a high ...
(Date:7/29/2014)... Kathleen Doheny HealthDay ... Healthy women at low risk of cardiovascular disease may be ... a short time without harming their hearts, according to a ... Initiative, found that hormone replacement therapy had harmful effects on ... they began the hormone treatments, and much further past menopause. ...
(Date:7/29/2014)... (PRWEB) July 29, 2014 iFitDress.com, one of ... its new selection of 2014 high low wedding dresses ... new gowns are offered at discounted prices, up to 68% ... the big discounts before August 05. , The ... of high low wedding dresses. In the new collection, there ...
(Date:7/29/2014)... WA (PRWEB) July 29, 2014 “Approximately ... one of the most common chronic illnesses,” Western Washington ... addressing the need for those suffering from allergies ... spent on allergy-related health care each year in the ... as a mere way of life for themselves, rather ...
(Date:7/29/2014)... "Acceptance, Recognition, and Control (A.R.C.) Against ... own demons and wants other men to heed the call ... A month later, he had no job, leaving Raymond with ... approached the government for assistance, the emotional disturbance was so ... But this approach didn’t get to the root of his ...
Breaking Medicine News(10 mins):Health News:Gummy Smile Surgeon, Dr. Alex Farnoosh, Now Offers Procedures to Improve Gummy Smiles and Dark Gums 2Health News:Early Hormone Therapy May Be Safe for Women's Hearts 2Health News:Early Hormone Therapy May Be Safe for Women's Hearts 3Health News:2014 High Low Wedding Dresses Provided By iFitDress.com 2Health News:Allergy Sufferers are Urged to Seek Medical Help in Recent Article by Western Washington Medical Group 2Health News:Allergy Sufferers are Urged to Seek Medical Help in Recent Article by Western Washington Medical Group 3Health News:SBPRA Announces the Release of Its Newest Title, "Acceptance, Recognition, and Control (A.R.C.) Against Depression" 2
... from Scripps Research Institute, have identified a sensor that identifies ... of glucose. It acts like a switch that increases or ... other times it helps to convert glucose into fat for ... named Liver X Receptor. Its dual function makes it a ...
... largely to the socializing that takes place there, according to ... keeping fit and losing weight but also for meeting new ... Professor of Social Sciences from the University of Manchester, spent ... motivating them to join health clubs. He wanted to study ...
... promises heavy investment opportunities for Non-Resident Keralites (NRK), making ... long term. ,Kerala Tourism Department has ... 23 – 27 for showcasing the opportunities in the ... a congregation of major hospitals, health insurance companies, policy ...
... malnutrition. In spite of hospitalization the survival rate is less ... a research published concerning certain clinical signs that would indicate ... are at greater risk. ,The international group of researchers ... where 920 children were admitted with severe malnutrition between Septemb ...
... A new study provides the strongest evidence yet that a ... testing and risk assessment// for toxins is wrong when it ... ,Edward J. Calabrese, a scientist at the University of Massachusetts ... 56,000 tests in 13 strains of yeast using 2,200 drugs, ...
... has for the first time identified several genes// whose expression ... cancers – lung, breast, prostate and colon cancer. ,The ... genes, is often lost in tumor cells. This can occur ... deletion of the gene. Loss of tumor suppression function also ...
Cached Medicine News:Health News:Glucose Sensor That Controls Glucose Metabolism Identified 2Health News:New Study Challenges How Regulators Determine Risk 2Health News:Profiling of Cancer Genes May Lead to Earlier Detection Human Cancers 2Health News:Profiling of Cancer Genes May Lead to Earlier Detection Human Cancers 3
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: