USP Monograph Development Process and Compendial Updates
USP Monograph Development Process and Compendial Updates
USP Monograph Development Process and Compendial Updates
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Residual Solvents• Classes of residual solvents based on toxicity– Class 1 – Highest toxicity; should be avoided in alldrugs– Class 2 – Less toxic, should be limited in all drugs– Class 3 – Low toxicity; generally deemed safe to 5000ppm or 0.5%– Other Solvents (“Class 4”) – No AdequateToxicological Data
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