Comparing Methods For Residual Moisture Analysis Of Lyophilized Products

By Suzanne Kuiper, PhD, Lighthouse Instruments

Many biopharmaceuticals rely on freeze drying to extend the shelf-life of these valuable materials. The residual moisture content after freeze drying is a critical product parameter since it can impact the reconstitution time, cake appearance and physical stability of the final product. Freeze drying processes should therefore be optimized per product formulation and, ideally, a residual moisture determination method should be available for these activities that enables efficient analysis of statistical sample sets. This article explores the different analysis techniques can be used to determine the residual moisture levels of freeze-dried product.