Stability Indicating Analytical Methods (SIAMS). Pharmaceutical Analysis

      Аннотация: This book reviews the regulatory aspects for the development of stability indicating Analytical methods (SIAMs).The main contemporary goal of SIAM is to give the information on condition for stress testing so as to found the stability of drug substances and product. SIAMs are used to distinguish the API from its potential decomposition product. Regulatory guidance in ICH Q1A (R2) ICH Q3B (R2) Q6A and FDA 21 CFR section 211 requires validated SIAMs. Force degradation is necessary to show the specificity when developing SIAMs and for this reason, it should be carried out prior to implementing the stability studies. Force degradation of drug standard and excipients is carried out under dissimilar conditions to determine whether the analytical method is stability indicating. The approaches for the development of stability indicating method is discussed.

Ключевые слова: Pharmaceutical Analysis, Validation Parameter