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Volume 2018 eBook, Issue 1
Understanding the advantages and suitability of different methods to measure residual moisture content in lyophilized materials--and the respective limitations--aids in selecting the most appropriate method for testing.
Many drug products that are unstable in the presence of water are lyophilized to increase stability and shelf life. Lyophilization is a process of preservation by removing water from the product to sufficiently low levels for adequate stability. This stability is achieved by limiting the potential for degradation upon storage caused by hydrolysis reactions with any remaining residual water, referred to as residual moisture. Residual moisture-considered a critical quality attribute (CQA)-can have a significant impact on the stability of a lyophilized product when stored in the dried state. The remaining water at the end of the process can be involved in hydrolysis reactions, which typically lead to degradation. The interaction of residual moisture, or more specifically of available water, on the lyophilized material can result in changes including degradation, crystallization, and collapse. Reconstitution of the drug product can also be affected. Residual moisture testing, therefore, requires a method that provides accuracy and precision to low levels.
eBook: Biologics and Sterile Drug Manufacturing
When referring to this article, please cite it as A. Bosch and E. Trappler, "Residual Moisture Testing Methods for Lyophilized Drug Products," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook (May 2018).