In a market each day more and more competitive and demanding, ensuring quality and safety of products offered to the consumers is a differential for companies. Additionally, regulatory agencies (ANVISA, MAPA, IBAMA) have increased the level of requirements for clearing registration of new products, as well as the maintenance of those already on the market. In this scene, stability studies play an essential part of registration procedures, as they are used for determining the expiration date of products.
Shelf-life stability – study designed to check the physical, chemical, biological and microbiological characteristics of an active pharmaceutical resource under normal storage conditions (30ºC x 65%RH – 30ºC x 75%RH). Results are used to determine the expiration date and to recommend storage conditions.
Accelerated stability – Study designed to accelerate chemical degradation and/or physical changes of active pharmaceutical and veterinary resources under forced storage conditions (54ºC-40ºC x 75%RH-50ºC x 90%RH). All data obtained, along with those from the shelf-life study, can be used to evaluate long-term chemical and physical effects under non-accelerated conditions and to evaluate the impact of short exposure periods to conditions not in the range mentioned in the product labeling, which may occur during transportation.