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Stability Analysis in Drug Development
Typology: Study notes
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Generate useful information of environmental factors (e.g., temperature, light, humidity etc.) that influence the quality of drug products. Establish the chemical, physical and microbiological changes how to influence the effectiveness, stability and safety of the final drug product.
Establish storage conditions
Solid-state stability analysis Solution-state stability analysis APIs-excipients compatibility analysis
Thermogravimetric Analysis (TG) Raman Spectroscopy FT-IR Spectroscopy Differential Scanning Calorimetry (DSC) High-performance Liquid Chromatography (HPLC) X-ray Diffraction
Data analysis Provide full study report