The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Guidance for Industry: Q3D(R2) – Guideline for Elemental Impurities
Origin/Publisher:
FDA
Content:
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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