USP <922> Water Activity Has Opened A Door For OSD Manufacturers

When water activity of an oral solid dosage product increases above a critical limit, objectionable organisms begin to grow.  If the Active Pharmaceutical Ingredient (API) is moisture sensitive, the degradation rate will increase exponentially as water activity increases, causing a loss in potency and an increase in the concentration of impurities. These 3 critical quality attributes are each controlled by the amount of free or loosely bound water in the tablet or capsule.

This short video explains more about USP <922> Water Activity and why using Karl-Fischer titration to measure total water content is no longer adequate to fully understand the stability of oral solid dosage products.