Stability Indicating Method (SIM)

 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)  or out-of-specification (OOS) results
 in quality control processes.