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Chapter
- Definition and Objective
- Need and aim of stability study
- Systematic approach
- ICH and Stability Guidelines
- Purpose
- Stress stability testing
- Selection of Batches
- Container closure system
- Specifications
- Testing Frequency
- Stability study conditions
- Storage condition
- Evaluation of stability data
- Significant Change
- Bracketing and Matrixing
- Global climatic zones
- Stability chamber
- Photo stability studies
- Mean Kinetic Temperature
- Stability Protocol
- INSTRUCTION FOR EVALUATION
- EVALUATION QUESTIONNAIRE
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