FDA Publishes Guidelines for Elemental Impurities in Drug Products

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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 a testing strategy for Elemental Impurities in finished products or raw ingredients, feel free to contact Chemical Solutions, Ltd.

Download Guideline for Elemental Impurities in Drug Products