USP Further Strengthens Heparin Standards

The US Pharmacopeial Convention’s Expert Panel on Unfractionated Heparin held a two-day meting in Rockville, MD, on May 16, 2012, to finalize a third round of revisions to the heparin quality standards. They are scheduled to be published in the November/December Pharmacopeial Forum. The latest revisions should bring greater accuracy to the test and reference materials used to ensure heparin quality, according to a US Pharmacopoeia (USP) press release.

The expert panel recommended improved procedures and tighter specifications for detecting and preventing the presence of over-sulfated chondroitin sulfate (OSCS). There will also be improved control of protein and nucleic acid impurities, states the release. FDA also requested that USP add a heparin molecular weight determination procedure—this will be part of the proposed revisions along with a related reference material.

In 2008, Baxter Healthcare recalled multiple and single dose heparin sodium for injection, as well as "HEP-Lock" heparin flush products, in response to FDA confirmed reports from China of adverse health events. OSCS was identified as the contaminant. In June 2008, USP responded to the heparin crisis by revising its heparin sodium and heparin calcium monographs—this was the first stage of the monograph modernization aimed at validating and implementing procedures to detect OSCS. Stage II, issued in 2009, included new identification, potency assay, and impurities procedures.

“A secure and safe drug supply is something that the public has come to expect and rightfully so,” said Roger L. Williams, USP’s chief executive officer in the press release. “Quality standards play a significant role in the overall safety net of regulations and controls that protect medicines in the US Developing and continuously improving standards based on the best science available are paramount.”