Navigation Links
USP Announces Revised Glycerin Monograph

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 For media inquiries, please email

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

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
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:
(Date:11/24/2015)... ... November 24, 2015 , ... The United States Golf ... the 2016 USGA Green Section Award. Presented annually since 1961, the USGA Green Section ... her work with turfgrass. , Clarke, of Iselin, N.J., is an extension ...
(Date:11/24/2015)... ... November 24, 2015 , ... International Society for Pharmaceutical Engineering ... premier annual events for pharmaceutical manufacturing: 2015 Annual Meeting. The conference took place ... the largest number of attendees in more than a decade. , “The ...
(Date:11/24/2015)... ... 2015 , ... The Academy of Model Aeronautics (AMA), led by its Executive ... Multirotor Grand Prix, to represent the First–Person View (FPV) racing community. , FPV racing ... this type of racing and several new model aviation pilots have joined the community ...
(Date:11/24/2015)... SAN FRANCISCO , Nov. 24, 2015 /PRNewswire/ ... today announced that Emily Leproust, Ph.D., Twist Bioscience ... Piper Jaffray Healthcare Conference on December 1, 2015 ... Palace Hotel in New York City. ... . Twist Bioscience is on ...
Breaking Biology Technology:
(Date:10/29/2015)... 29, 2015 Daon, a global leader in ... released a new version of its IdentityX Platform ... North America have already installed IdentityX v4.0 ... a FIDO UAF certified server component as ... activate FIDO features. These customers include some of the ...
(Date:10/29/2015)... , Oct. 29, 2015  Connected health pioneer, ... the explosion of technology-enabled health and wellness, and the ... book, The Internet of Healthy Things ... or smartphones even existed, Dr. Kvedar, vice president, Connected ... health care delivery, moving care from the hospital or ...
(Date:10/29/2015)... , Oct. 29, 2015 Today, ... a partnership with 2XU, a global leader in ... a smart hat with advanced bio-sensing technology. The ... athletes to monitor key biometrics to improve overall ... partnership, the two companies will bring together the most ...
Breaking Biology News(10 mins):