Stability Studies Analysis
In pharmaceutical products, irreversible chemical, physical, or microbiological processes may occur over time, which can impact the stability of the active ingredient or excipients. The extent and speed of these processes may be influenced by the inherent characteristics of the formulation within its primary packaging or external factors such as temperature, light, air, or humidity.
Stability studies are conducted to determine the shelf life and storage conditions under which pharmaceutical products remain compliant with specifications regarding their identity, potency, purity, and attributes related to efficacy and safety.
The stability of pharmaceutical products in their final primary packaging must be substantiated using appropriate methods. These methods should be customized to suit the pharmaceutical form of the product being studied.
Recognizing the client's requirements and the significance of ensuring quality, effectiveness, and safety throughout the product's shelf life, Lambda's objective is to provide support for the execution of these analyses with the utmost quality and analytical expertise, in compliance with NOM-073-SSa1-2015, Stability of Drugs and Medicines, as well as Herbal Remedies (excluding storage in environmental chambers).