Indicative content
1. Stability indicating methods (SIM):
Hydrolysis, Oxidation, Photolysis and Photo stability studies, Realistic and focussed product degradation ,Stress testing and representative sampling, Over and under stressing, Thresholds for drug degradation as percentage of total daily intake (TDI), Investigation of Out of trend (OOT) and out of Specification (OOS) results, LOD, LOQ
2. Analytical methodologies:
LC, GC, Spectroscopy, NIR, Raman Spectroscopy, UV Spectroscopy and Particle size analysis, dissolution testing. Determination of stability indicating methods.
3. Stability types Physical, Microbiological, therapeutic and toxicological, Stages in life cycle from Stage 1 to on-going i.e. clinical trial follow up stability trials. Photo stability studies. Extrapolation of data to indicate stability of product. Pharmaco-kinetics.
4. Container closure systems, packaging and dosage form and their impact of stability and shelf life. Bracketing and matrixing to reduce size of stability studies. SUPAC. Statements for label information and investigation of OOS results encountered during analysis.
5. Stability of Bio molecules
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