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By Jennifer Riter

January 12, 2018

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, which historically was used to test for heavy metals in drug products as well as packaging components, has been withdrawn.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

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By West&#39;s Scientific Affairs Team

April 25, 2017

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.