Jennifer Riter

Sr. Director, Labs Services, SA & TS

January 12, 2018

Alert: USP <381> Revision Bulletin

On January 1, 2018, new USP standards became mandatory for measuring elemental impurities in pharmaceuticals and their ingredients – aligning with ICH Q3D, which provides limits for the amount of elemental impurities in drug products. New USP General Chapters, USP <232> (Elemental Impurities – Limits) and USP <233> (Elemental Impurities – Procedures) have replaced USP <231> (Heavy Metals). USP <231>, which historically was used to test for heavy metals in drug products as well as packaging components, has been withdrawn. However, the heavy metals testing in USP <381> (Elastomeric Closure for Injections), which is used for testing of elastomeric closures, still references USP <231>.

Scientist performing tests in a lab

A proposed change for the USP <381> extractable elements was made in March 2017, but has not yet been approved or published. Due to this, USP issued a Revision Bulletin on December 29, 2017 indicating that the Packaging and Distribution Expert Committee had revised USP <381> to include the historic USP <231> heavy metals tests to enable continued use. The revision became effective on January 1, 2018, and will remain in effect until the USP <381> extractables elements proposal can be approved and published. The Revision Bulletin can be found here

According to Desmond G. Hunt, Ph.D., Principal Scientific Liaison, USP, “USP is currently reviewing the comments obtained from the Pharmacopeial Forum (PF) 44 (3) revision proposal of <381> and is still working to include an updated method for the testing of extractable metals from elastomeric components for injectable drug products. The Committee is working to have a revised chapter, based on stakeholder comments, republished in PF by the end of the year.”

West follows this very closely. For more information, contact a Technical Customer Support (TCS) representative.