The United States Pharmacopeia (USP) will release the new method USP <922> in May 2021, which will outline recommendations for the determination of water activity. It includes a brief theoretical background explanation, the best practices for water activity measurement and an overview of potential applications for water activity in pharmaceutical products.
USP <1112>, the first informational chapter on water activity published by USP back in 2006, did not provide guidance or instructions on best practices for water activity measurement. The new method USP <922> now addresses these limitations and highlights the potential of water activity measurement in the pharmaceutical industry.
“Water activity has the potential to eliminate many safety and quality related issues in pharmaceutical products, resulting in less waste and higher revenue, “states Dr. Brady Carter, Senior Application Scientist and water activity expert with Novasina and Neutec Group. Applications include optimized formulation, microbial risk prevention, stability control, optimized formulation, reduced caking and clumping, and moisture migration control. Therefore water activity should be included in every drug release program.
“Novasina water activity meters are specially designed for the unique requirements of pharmaceutical testing labs, with an emphasis on accuracy and 21 CFR part 11 compliance,” states Ronen Neutra, President at Neutec Group, which distributes and supports Novasina instruments in the US and Canadian markets. “We are excited to now be able to match these quality water activity instruments to an official USP water activity method, USP <922>.”
Want to learn more about Water Activity and USP <922> ? Click here for an application note on USP 922