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Stability Indicating Methods - cdn.intechweb.org
3. Stability Indicating Methods Ana Paola Cione, Edivan Tonhi and Paulo Silva Bioagri Laborat rios Brazil 1. Introduction How define a SIM? According to FDA guideline (Guidance for Industry, Analytical Procedures and Methods Validation, FDA, 2000), a Stability Indicating Method (SIM) is defined as a validated analytical procedure that accurate and precisely measure active ingredients (drug substance or drug product) free from process impurities, excipients and degradation products. The FDA recommends that all assay procedures for Stability should be Stability Indicating . The main objective of a Stability Indicating method is to monitor results during Stability studies in order to guarantee safety, efficacy and quality. It represents also a powerful tool when investigating out-of-trend (OOT) (Swartz et al.)
Stability Indicating Methods 29 1.2.2 Step 2: method development (manipulating and evaluating selectivity/specificity) Liquid chromatography is the most appropriate technique for developing/validating a SIM.
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