Stability Indicating Methods

1.1 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., 2004) or out-of-specification (OOS) results (CDER, 2006) in quality control processes.

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