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FDA Guidance for Industry: Q3D(R2) – Guideline for Elemental Impurities



The guidance applies to new finished drug products (as defined in the ICH guidances for industry Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (December 2000 (ICH Q6A) and Q6B Substances: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (August 1999) (ICH Q6B)5 and new drug products containing existing drug substances

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