Why Add Water Activity To The Stability Test Protocol

The recently implemented USP <922> chapter describes how water activity measurements enable the generation of critical product information in the stability test protocol. Measurement and control of Water Activity is critical to ensure the stability of any moisture sensitive API or formulation. By adding Water Activity to the stability test protocol you will collect critical product information:

• Determine how water activity of the packaged drug product increases during the stability test period;
• Generate the sorption isotherm of your specific formulation;
• Characterize the humidity impact on the degradation rate of your drug product.

This fragment from our webinar on USP <922> Water Activity Testing, describes a framework on how by adding water activity measurements to stability protocols will achieve to improve the quality program.