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Elemental impurities, such as arsenic, cadmium, lead and mercury are ubiquitous in nature. They are also toxic to humans and animals at certain levels. Because these elements are often part of mined minerals used in the manufacture of drug products and/or drug containment systems, they can have an impact on the quality of a drug.

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, which historically was used to test for heavy metals in drug products as well as packaging components, has been withdrawn.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

Material characterization is an important part of the selection process of containment/delivery systems for parenteral drug products.