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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, which historically was used to test for heavy metals in drug products as well as packaging components, has been withdrawn.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>.

Compendial documents developed by both international and national organizations outline specifications for elastomeric components that are used in packaging of parenteral drug products. These specifications often are not harmonized; not all compendia specify the use of the same tests, and some tests that are used globally have varying specifications. Understanding these specifications and how they influence packaging/delivery of parenteral drug products in global markets is critical.