Residual Moisture Testing Methods for Lyophilized Drug Products

May 15, 2018
Edward H. Trappler

Ed Trappler is president and founder of Lyophilization Technology, Inc. a contract research and technical services firm dedicated to freeze drying. He has over 40 years of experience in lyophilization that ranges from product development to equipment application engineering. He received his Bachelor of Science degree in chemistry at The College of New Jersey. His experience in the pharmaceutical industry includes product development, toxicology supply preparation, clinical manufacturing and parenteral production.

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Amy M. Bosch

Amy M. Bosch is Scientist I at Lyophilization Technology, Inc. (LTI). As a Scientist I and Project Director, she is involved in managing client projects including product and process development, clinical and toxicological material preparation, technical support, and troubleshooting. Amy holds a B.S. degree from Millersville University in Biology.

Pharmaceutical Technology, Pharmaceutical Technology-05-15-2018, Volume 2018 eBook, Issue 1
Page Number: 30–38

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. 

Read this article from Pharmaceutical Technology’s Biologics and Sterile Drug Manufacturing 2018 eBook.

Article Details

Pharmaceutical Technology
eBook: Biologics and Sterile Drug Manufacturing
Vol. 42
May 2018
Pages: 30-38

Citation

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).