Due to the prevalence of contaminated heparin products that have resulted in more than 80 deaths, USP has revised its monographs for Heparin Sodium and Heparin Calcium. These "Stage 1" revisions to the monographs are accompanied by two new and two existing USP Reference Standards. USP will continue efforts to revise these two heparin drug substance and related drug product monographs in future, Stage 2 revisions. Stage 2 revisions include consideration of new methodologies for identification, the development of a new potency assay and tests for impurities.
USP will review and undergo revision of the monograph
Stage 1 Monograph Revisions
Stage 2 Monograph Revisions
USP will be focusing Stage 2 activities on new methodologies for identification, the development of a new potency assay and tests for impurities