Navigation Links
U.S. Pharmacopeia Aiding FDA in Improved Tests for Heparin Contamination
Date:4/14/2008

Suspected Contaminant Mimics Heparin

ROCKVILLE, Md., April 14 /PRNewswire/ -- The United States Pharmacopeial (USP) Convention announces that it is working with the Food and Drug Administration (FDA) to develop more sensitive methods for detecting contaminants recently found in the widely used blood-thinning drug heparin. This contamination is suspected of causing severe allergic reactions in some patients and has resulted in over 60 deaths. The suspected contaminant, over-sulfated chondroitin, is derived from the dietary supplement chondroitin. The chemically-induced over-sulfated form can mimic blood-thinning properties. Consequently, heparin adulterated in this manner may pass existing quality tests. It is likely (but still being determined) that any deliberate adulteration was done for economic reasons, because over-sulfated chondroitin is a much less expensive ingredient than genuine heparin.

USP publishes official quality standards for medicines in the United States Pharmacopeia-National Formulary (USP-NF) and has worked with FDA for over 100 years in a unique public-private partnership that helps assure the quality of medicines in the United States. Following a recall in January of suspect heparin products, FDA in March asked USP to assist in re-assessing current tests and possibly developing new methods for detecting over-sulfated chondroitin in the heparin drug substance before it is made into a final product. This work is ongoing and will result in updated heparin monographs. Heparin has been sold in the United States since the 1940s and has had a USP monograph since 1950, which has been updated several times.

According to Roger L. Williams, M.D., USP's chief executive officer, "It is difficult for analytical procedures to detect and identify all adulterants. USP monographs are designed to test for known impurities that result from manufacture or degradation, not for unknown contaminants that may be added either accidentally or deliberately. USP will continue to work closely with FDA and other partners to develop the most effective approaches to assure the safety of heparin."

The availability of a good public monograph in the USP with allied reference materials is one of a series of safety nets that work to assure that U.S. patients and practitioners have access to good quality medicines. Other safety nets include dedicated and trusted drug ingredient and product manufacturers who follow good manufacturing practices (GMPs) and sound sampling protocols in support of batch release testing. Oversight from FDA is also key in assuring product quality along complicated and at times lengthy supply and distribution pathways.

USP will provide further information as its work evolves. For updates on the availability of this information, please contact Laura Provan at lnp@usp.org or 301-816-8268.

USP -- Advancing Public Health Since 1820

The United States Pharmacopeia (USP) is a private, non-profit, standards-setting organization that advances public health by helping to ensure the quality and consistency of medicines, food ingredients, and dietary supplements, promoting the safe and proper use of medications, and verifying ingredients in drugs and dietary supplements. Its standards, which are recognized worldwide, are developed by a unique process of public involvement through the contributions of volunteers representing pharmacy, medicine, and other health care professions, as well as science, academia, government, the pharmaceutical and food industries, and consumer organizations. For more information about USP and its public health programs, visit http://www.usp.org/newscenter.


'/>"/>
SOURCE U.S. Pharmacopeia
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. U.S. Pharmacopeia Releases New Edition of the Food Chemicals Codex
2. US Pharmacopeia releases new edition of the Food Chemicals Codex
3. Pharmacopeia to Present at The Roth 20th Annual OC Growth Stock Conference
4. USP publishes Spanish edition of United States Pharmacopeia and National Formulary
5. USP Publishes Spanish Edition of United States Pharmacopeia and National Formulary
6. U.S. Pharmacopeia 8th Annual MEDMARX(R) Report Indicates Look-Alike/Sound-Alike Drugs Lead to Thousands of Medication Errors Nationwide
7. US Pharmacopeia partners with Quantros to enhance the MEDMARX patient safety reporting program
8. Pharmacopeia and GlaxoSmithKline Collaboration Identifies Two Additional Lead Compounds
9. Pharmacopeia Acquires Selective Androgen Receptor Modulator (SARM) Program from Bristol-Myers Squibb
10. Pharmacopeia Announces Senior Additions to Management Team
11. Twin findings raise hopes of improved anemia treatments
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating ... Millions of individuals in the United States and Canada wear eyeglasses. Once considered to ... correct vision and make a fashion statement. Even celebrities use glasses as a way ...
(Date:6/26/2016)... ... ... Kasmer, a legally blind and certified personal trainer is helping to develop a weight loss ... plans to fix the two major problems leading the fitness industry today:, ... , They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... ... 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily ... of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures ... . Simply select a ProHand generator and drag it above media or text in ...
(Date:6/25/2016)... Canada (PRWEB) , ... June 25, 2016 , ... Conventional ... pursuit of success. In terms of the latter, setting the bar too high can ... risk more than just slow progress toward their goal. , Research from ...
(Date:6/24/2016)... ... 24, 2016 , ... The Pulmonary Hypertension Association (PHA) learned ... receive two significant new grants to support its work to advance research and ... by recognizing patients, medical professionals and scientists for their work in fighting pulmonary ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... Jazz Pharmaceuticals plc (Nasdaq: JAZZ ... Antitrust Improvements Act of 1976, as amended ("HSR"), with ... ("Celator"; Nasdaq: CPXX ) expired effective June ... As previously announced on May 31, 2016, Jazz ... under which Jazz Pharmaceuticals has commenced a tender offer ...
(Date:6/26/2016)... 2016 Story Highlights: ... within the health care industry is causing providers to ... , Deloitte offers a suite of solutions for health ... efficient cost optimization: labor resource analysis, revenue cycle optimization ... better outcomes and better economics ...
(Date:6/24/2016)... 24, 2016  Collagen Matrix, Inc., ("Collagen Matrix") ... manufacturing of collagen and mineral based medical devices ... Bill Messer has joined the company ... leverage the growing portfolio of oral surgery, neurosurgery, ... Bill joins the Collagen Matrix executive team as ...
Breaking Medicine Technology: