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Guidelines for Residual Solvents in Pharma by Hammam Hafidzurahman is a document available to read on EtoBox.

What is Guidelines for Residual Solvents in Pharma about?

This document discusses classification and limits of residual solvents in pharmaceutical products. It defines residual solvents and classifies them into three categories based on toxicity: Class 1 (avoid), Class 2 (limit), and Class 3 (low toxic potential). Class 1 solvents are known or suspected human carcinogens. Class 2 solvents are suspected of reversible toxicity. Class 3 solvents have low toxic potential and their limits are set at 50 mg/day without justification. The document provides procedures for

Author

Hammam Hafidzurahman

Language

EN