TG,TG/MS, and Vapor Pressure Moisture: Applications to Determination of Residual Moisture in BCG Vaccine and Other Freeze-Dried Biological Products

摘要

TG,TG/MS, and loss-on-drying methodology are used to provide residual moisture results for freeze-dried biological products regulated by the US Food and Drug Administration. Residual moisture specifications must be met in order to ensure freeze-dried biological product potency and stability throughout the product’s licensed shelf life. TG, TG/MS, loss-on-drying and vapor pressure moisture measurements are compared for a BCG Vaccine. Comparisons are made between residual moisture data for the freeze-dried cake and vapor pressure moisture determinations in the space above the freeze-dried cake in the final container. Vapor pressure moisture precision data is presented for a–Interferon and BCG Vaccine. Impact of residual moisture and vapor pressure moisture upon product stability is presented.