Impurities in residual solvents

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INTRODUCTION SCOPE OF GUIDELINES CLASSIFICATION LIMITS OF RESIDUAL SOLVENTS ANALYTICAL PROCEDURES REPORTING LEVELS OF RESIDUAL SOLVENTS RESIDUAL SOLVENTS IN PHARMACEUTICALS GLOSSARY

IMPURITIES IN RESIDUAL SOLVENTS
ADVANCED PHARMACEUTICAL ANALYSIS
Submitted by
B. Mamatha
M.Pharmacy 1-1
Pharmaceutical Analysis

these slides discuss Impurity profiling Degradation characterization Stability testing & Accelerated stability testing (ICH) Evaluation of the test (shelf life) analytical method development ICH vs USP definition methods for identification method for the isolation of the impurity factors affecting the degradation of formulation What is degradation characterization general protocol of degradation conditions used for drug substance and drug product Degradation conditions Stress testing Container closure system

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