Analytical services supporting stability programs include: long-term stability testing, accelerated stability testing, comparative stability testing, forced degradation studies, and stability testing of Active Pharmaceutical Ingredient (API), Clinical Trial Material (CTM), and commercial products.
All chambers are continuously monitored by a computerized status monitoring system. Temperature and humidity set point windows are ±2°C and ±5% RH, respectively, with deviations outside set point ranges resulting in an immediate alert to Formex staff.
Formex tests raw materials in accordance to USP/NF, EP, JP or material manufacturer’s specifications. The release attributes and compendia followed are dependent on the intended use and planned phase of study for the drug product. For non-compendial materials Formex can development and validate methods in order to maintain cGMP compliance; thus, expanding the development options available to formulators.