USP Posts Revised Heparin Monographs

Rockville, MD (June 18)-The US Pharmacopeia (USP) posted revised monographs for heparin sodium and heparin calcium on its website. The US Food and Drug Administration asked USP to revise the heparin standards following recent reports of serious injuries and deaths associated with heparin containing adulterated active pharmaceutical ingredients from China.

The new monographs are Stage 1 revisions. On its website, USP says the revisions are intended to rapidly address the public-health crisis and ensure an unadulterated heparin supply. The organization improved the resolution of FDA’s capillary electrophoresis (CE) method by changing the concentration of heparin to 2 mg/mL and the injection time to 30 s.

USP is at work on Stage 2 revisions of the monographs, which will consider new methodologies for identification, introduce a new potency assay, and describe tests for impurities. Changes to USP’s heparin-product monographs and low-molecular-weight heparins also will be considered in the Stage 2 revisions.

The organization states that CE and nuclear magnetic resonance methods are needed to quickly allow for a qualified supply of heparin and to address the current adulteration of the heparin supply. These methods will be a provisional solution until Stage 2 revisions are complete. USP releases methods that have been validated with specific parameters and recommends that manufacturers validate the methods before using them.

In addition to the revised monographs, USP posted two new and two existing reference standards on its website. The new reference standards are “USP Heparin Sodium Identification RS” and “USP Heparin System Suitability RS.” The old reference standards are “USP Endotoxin RS” and “USP Heparin Sodium RS.” The current “USP Heparin Sodium, Lot L” reference standard is not affected by the revision and is not for use in the new identity tests. USP’s sodium heparin reference standard is still for use in the sheep-plasma clotting assay.