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Eudralex Volume 3 Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (ICH Q6A) CPMP/ICH/ 367/96-ICH Q6A
Origin/Publisher:
EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Content:
This guideline is intended to assist to the extent possible, in the establishment of a single set
of global specifications for new drug substances and new drug products. It provides guidance
on the setting and justification of acceptance criteria and the selection of test procedures for
new drug substances of synthetic chemical origin, and new drug products produced from
them, which have not been registered previously in the United States, the European Union, or
Japan.
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