Search results with tag "Impurities guideline for residual"

IMPURITIES GUIDELINE FOR RESIDUAL S Q3C(R8) - ICH

1 PART I: IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 17 July 1997, this Guideline is recommended for adoption to the three regulatory parties to ICH 1. INTRODUCTION The objective of this guideline is to recommend acceptable amounts for residual solvents in

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