Stability Indicating Analytical Method Development and Validation
Journal: International Journal of Pharmaceutical Sciences and Medicine (IJPSM) (Vol.7, No. 11)Publication Date: 2022-11-30
Authors : Aarti Yadav; Dubey Raghvendra;
Page : 33-50
Keywords : Analytical method development; Stability indicating analytical methods; Validation; Regulatory guidelines;
Abstract
This write-up provides a review on the stability indicating analytical method development and validation. This review provides a basic detail about analytical method development, stability indicating analytical methods and validation as per regulatory guidelines and current scenario. What kind of content required for analytical procedure, steps involve in development of stability indicating analytical procedure also described. Details of Validation and its parameter like Specificity, Linearity, Range, Accuracy, Precision, Detection limit, Quantitation limit, Robustness, System suitability testing given.
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Last modified: 2022-11-21 22:09:59