Method Development for Moisture Analysis in Lyophilized Products

Quality, efficacy and shelf-life of lyophilized pharmaceutical products and ingredients is highly dependent on water content. Routine Karl Fischer (KF) titration is the preferred technique for measuring residual moisture levels compared to other methods such as loss on drying, but, failure to properly optimize solubility and extraction may cause inaccurate water content results.

Watch this webcast to hear Jacob Butler, quality control specialist at Organon Teknika Merck, describe his experience with manual solvent and oven extraction method development. Jacob will present a case study that demonstrates both determination of optimal oven temperatures and how to build an oven method for method validation.