Stability studies guarantees that quality attributes will be maintained during a period under the influence of a variety of environmental factors, consequently maintaining drug product efficacy and safety. In this context, stability indicating analytical methods (SIAM) appears as a regulatory requirement to detect common observed impurities and those likely to appear during product shelf-life due to degradation. U.S. Food and Drug Administration (U.S. FDA), The International Council on Harmonization of Technical Requirements for Medicinal Products for Human Use (ICH), World Health Organization (WHO), European Medicine Agency (EMA) have been discussing SIAM concepts and applications, as well as other scientific organisms. Brazilian Health Regulatory Agency (Anvisa) approached SIAM concept through regulations and guidelines in 2015. Hereupon this note intends to expose Brazilian requirements for drug products registration related to SIAM by establishing a comparison to international scenario.

稳定性研究保证了在各种环境因素影响下的一段时间内可以保持质量属性，从而保持了药品的功效和安全性。在这种情况下，稳定性指示分析方法（SIAM）似乎已成为检测常见杂质以及由于降解而在产品保质期内可能出现的杂质的法规要求。美国食品药品监督管理局（US FDA），国际人用药用产品技术要求协调委员会（ICH），世界卫生组织（WHO），欧洲药品管理局（EMA）一直在讨论SIAM的概念和应用，以及其他科学有机体。巴西卫生监管局（Anvisa）在2015年通过法规和指南采用了SIAM概念。