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September 27, 2016
FDA Publishes Guidelines for Elemental Impurities in Drug Products
On June 30, 2016, the FDA released updated guidelines for Elemental Impurites in Drug Products. The update coincides with USP’s recent harmonization of Elemental Impurities within General Chapters 232 and 233. At FDA’s recent conference, implementation of these guidelines were reviewed in detail, from Risk Assessment through testing strategies. Should you require guidance in implementing… Read More >
