impurities in new drug substances 1.pptx

impurities in new drug substances 1.

1. Impurities in New Drug Substances and Products

2. Introduction to Impurities Definition: Impurities are unwanted chemicals present in a drug substance.They can affect drug safety, efficacy, and stability.Sources of impurities: Raw materials, manufacturing processes, degradation, storage conditions.

3. Classification of Impurities Organic Impurities:Starting materials, by-products, intermediates, degradation products.Inorganic Impurities:Residual metals, catalysts, salts, reagents.Residual Solvents:Organic and inorganic solvents left after synthesis.

4. Regulatory Guidelines & Control ICH Q3A & Q3B Guidelines define impurity limits.USP, BP, IP provide testing methods.Impurity control through:Good Manufacturing Practices (GMP)Analytical techniques (HPLC, GC, MS, etc.)Stability studies & forced degradation tests

5. Conclusion & Importance Impurities must be monitored, controlled, and minimized.Proper analytical techniques & regulatory compliance ensure drug safety & efficacy.Future trends: Advanced analytical techniques & AI-based impurity prediction.