Stress Degradation Studies and Stability-Indicating Analytical Methods

Stress Degradation Studies and Stability-Indicating Analytical Methods

EnglishPaperback / softbackPrint on demand
Baig, Mirza Shahed
LAP Lambert Academic Publishing
EAN: 9786139917419
Print on demand
Delivery on Friday, 21. of February 2025
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Detailed information

Quality of any Active Pharmaceutical Ingredient (API) or drug product for patient compliance is directly depending on stability of drug. The ICH drug stability test guideline Q1A (R2) requires that analysis of stability samples should be done through the use of validated Stability indicating assay methods (SIAMs) that can detect the changes with time in the chemical, physical, or microbiological properties of the drug substance and drug product, and that are specific, so that the contents of active ingredient, degradation products, and other components of interest can be accurately measured without interference. A proactive approach in developing a SIAMs involve forced degradation at the early stages of development with the key degradation samples used in the method development process.
EAN 9786139917419
ISBN 6139917417
Binding Paperback / softback
Publisher LAP Lambert Academic Publishing
Pages 428
Language English
Dimensions 220 x 150
Authors Baig, Mirza Shahed; Dehghan, M. H.