The new USP<922> Water Activity chapter expands requirements beyond USP<921> Water Determination testing

Description:
USP<921> Water Content measurements have been a critical quality attribute for 3-decades, typically using Karl Fisher titration to determine the water content of pharmaceutical products. USP published a new General Chapter <922> Water Activity determination in May 2021 in the USP-NF 45. Pharmaceutical companies can now reference USP<922> in all their regulatory filings including the stability section of the IND's, the Chemistry and Manufacturing Controls (CMC) section of their NDA, and all post-approval changes related to primary packaging of oral solid dose pharmaceuticals.

Water Activity is a measurement of the chemical potential of water and this therefore provides the critical insight into the risk of undesirable chemical, physical and microbiological reactions. Changes in purity, potency, disintegration, dissolution, hardness, swelling, friability and microbial growth all correlate to water activity. By implementing or expanding water activity testing, pharmaceutical firms will have the data that is expected and required by the regulators as they review new filings.

Water Activity data will be used during the entire product life cycle of oral solid dose products, by the formulation development, process development and packaging selection teams. The QC teams will use the water activity methods to release raw materials, monitor the tablet or capsule during the manufacturing process, approve the batch for release and monitor changes during long-term stability testing.

Speaker: Jeff Horsman - Lighthouse Instruments