Guidance for Industry: Impurities: Residual Solvents, VICH GL18. Draft Guidance.211 Recommended for Consultation at Step 4 of the VICH Process, May 18-20, 1999

摘要

The objective of this guidance is to recommend acceptable amounts for residual211u001esolvents in pharmaceuticals for the safety of the target animal as well as for 211u001ethe safety of residues in products derived from treated food producing animals. 211u001eThe guidance recommends use of less toxic solvents and describes levels 211u001econsidered to be toxicologically acceptable for some residual solvents.