Navigation Links
USP Announces Revised Glycerin Monograph
Date:3/17/2008

New Monograph Strengthens Safety Nets to Prevent Serious Health Hazards

Associated with Diethylene Glycol

ROCKVILLE, Md., March 17 /PRNewswire/ -- The U.S. Pharmacopeial (USP) Convention today announced a revised Glycerin monograph in the United States Pharmacopeia (USP), an official compendium of the United States. The revision strengthens safety nets to prevent serious and potentially fatal health hazards associated with diethylene glycol-contaminated glycerin. Glycerin is used as a sweetener in formulations of many pharmaceutical syrups and in other consumer articles as well, such as toothpaste. Diethylene glycol is a poisonous chemical used in industrial solvents and antifreeze. Over many years, accidental or intentional adulteration of drugs with diethylene glycol has occurred many times and in many countries, most recently in Panama in 2007 and, notably for the United States, in 1938. The 1938 episode killed over 100 American citizens, many of them children, and led to passage of the Federal Food, Drug and Cosmetic Act. Since that time, FDA and USP have worked together to prevent other such disastrous events.

In May 2007, FDA issued a "Guidance for Industry Testing of Glycerin for Diethylene Glycol." This Guidance emphasized the importance of screening ingredients and products for the presence of diethylene glycol. FDA and USP also worked together to change the current Glycerin monograph in USP. This change will require drug product manufacturers using glycerin -- not just the glycerin manufacturer -- to prove that diethylene glycol is not present, using the USP Glycerin monograph.

"This change in the USP Glycerin monograph is one of many safety nets that help assure U.S. citizens that the drugs they use are of good quality," said Roger L. Williams, M.D., USP's executive vice president and chief executive officer. "In some areas, these safety nets still need strengthening. For example, other useful ingredients similar to glycerin may be susceptible to diethylene glycol contamination. USP is working now to adjust monographs for these ingredients, just as it has the USP Glycerin monograph."

The revision of the USP Glycerin monograph becomes official May 15, 2008. It addresses adulteration/contamination of glycerin with the following changes:

1. Revision of Identification -- B. In the Identification B procedure of

the monograph, a gas-liquid chromatographic with flame ionization

detection (GC/FID) test will be employed to confirm the absence or

presence of glycerin, diethylene glycol and ethylene glycol by a peak

at the relative retention times for glycerin, diethylene glycol and

ethylene glycol. Where a peak is present for either of the impurities

in this procedure at their respective relative retention times, the

monograph will direct the user to quantify the impurities.

2. Replace the test "Limit of diethylene glycol and related compounds." A

new procedure, Diethylene glycol and ethylene glycol impurities,

capable of quantifying diethylene glycol and ethylene glycol at or

above the Limit of quantitation (0.025%) is added. This diethylene

glycol and ethylene glycol impurities test will be added to ascertain

the level at which these impurities are present.

The revised Glycerin monograph also will appear in Supplement 2 to USP 31- NF 26, which will be published in June 2008. For more information, please contact Robert Lafaver, USP scientist and liaison to the Excipient Monographs 1 Expert Committee, at 301-816-8335 or rhl@usp.org. For media inquiries, please email mediarelations@usp.org.

USP -- Advancing Public Health Since 1820

The United States Pharmacopeia (USP) is a private, non-profit, standards- setting organization that advances public health by ensuring the quality and consistency of medicines, promoting the safe and proper use of medications, and verifying ingredients in dietary supplements. These 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 industry, and consumer organizations. For more information about USP and its four public health programs, visit http://www.usp.org/newscenter.


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

Related biology technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. YM BIOSCIENCES ANNOUNCES COMPLIANCE WITH AIM RULE 26
3. Emisphere Technologies, Inc. Announces Pricing of Registered Direct Offering
4. BioLife Solutions Announces Exclusive CryoStor(TM) Supply Agreement With the New England Cryogenic Center, Inc.
5. Carrington Announces Nasdaq Communication; Prepares for Shares to Be Quoted on the OTC Bulletin Board and Pink Sheets
6. China Kangtai Cactus Biotech Files 2nd Quarter 2007 10QSB and Announces Unaudited Quarterly Results
7. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
8. Advanced Life Sciences Announces Receipt of Nasdaq Staff Letter
9. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
10. Angiotech announces additional diameters of sutures to further expand its Quill(TM) SRS PDO product line
11. CNS Response Announces Fiscal Third Quarter 2007 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... CA (PRWEB) , ... June 27, 2016 , ... ... for clinical trials, announced today the Clinical Reach Virtual Patient Encounter CONSULT ... care circle with the physician and clinical trial team. , Using the CONSULT module, ...
(Date:6/24/2016)... TOKYO , June 24, 2016  Regular discussions on ... to take place between the two entities said Poloz. ... in Ottawa , he pointed to the ... and the federal government. ... Poloz said, "Both institutions have common economic goals, why not ...
(Date:6/23/2016)... , ... June 23, 2016 , ... ... pleased to announce the launch of their brand, UP4™ Probiotics, into Target stores ... 35 years, is proud to add Target to its list of well-respected retailers. ...
(Date:6/23/2016)... ... 2016 , ... Charm Sciences, Inc. is pleased to announce ... Research Institute approval 061601. , “This is another AOAC-RI approval of the Peel ... President of Regulatory and Industrial Affairs. “The Peel Plate methods perform comparably to ...
Breaking Biology Technology:
(Date:6/22/2016)... On Monday, the Department of Homeland Security (DHS) issued ... the Biometric Exit Program. The Request for Information (RFI), ... that CBP intends to add biometrics to confirm when ... , in order to deter visa overstays, to ... Logo - http://photos.prnewswire.com/prnh/20160622/382209LOGO ...
(Date:6/16/2016)... FRANCISCO , June 16, 2016 ... size is expected to reach USD 1.83 ... by Grand View Research, Inc. Technological proliferation and ... banking applications are expected to drive the market ... ) , The development of advanced ...
(Date:6/9/2016)... -- Paris Police Prefecture ... to ensure the safety of people and operations in several ... tournament Teleste, an international technology group specialised in ... that its video security solution will be utilised by ... safety across the country. The system roll-out is scheduled for ...
Breaking Biology News(10 mins):