ANDAs impurities in drug substances - Pharmanet

Draft-Not for ImplementationTABLE OF CONTENTSI. INTRODUCTION .....................................................1II. CLASSIFICATION OF IMPURITIES .....................................3III. RATIONALE FOR THE REPORTING AND CONTROL OF IMPURITIES ........3A. Organic Impurities ...............................................3B. Inorganic Impurities ..............................................4C. Residual Solvents ................................................5IV. ANALYTICAL PROCEDURES ..........................................5V. REPORTING IMPURITY CONTENT OF BATCHES .........................5VI. ACCEPTANCE CRITERIA FOR IMPURITIES ..............................6VII. QUALIFICATION OF IMPURITIES ......................................8VIII. NEW IMPURITIES ...................................................11ATTACHMENT I — Impurities Decision Tree (Generic Drugs) .......................12ATTACHMENT II — ICH Decision Tree for Safety Studies .........................13ATTACHMENT III — Glossary of Terms .......................................14J:\!GUIDANC\2452DFT.WPDJuly 21, 1998i