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Search results with tag "Impurities in new drug substances"
IMPURITIES IN EW DRUG SUBSTANCES Q3A(R2)
www.ich.orgIMPURITIES IN NEW DRUG SUBSTANCES ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 7 February 2002, this guideline is recommended for adoption to the three regulatory parties to ICH.
IMPURITIES IN EW DRUG SUBSTANCES Q3A(R2)
www.ich.orgImpurities in New Drug Substances 3 Acceptance criteria should be based on pharmacopoeial standards or known safety data. 3.3 Solvents The control of residues of the solvents used in the manufacturing process for the new