Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drugs and Biologics Office of Biologics Research and Review 8800 Rockville Pike 20892 Bethesda Maryland USA
Thermogravimetry/mass spectrometry is used to identify TG transitions corresponding to loss of residual moisture in freeze-dried biological products with complex TG curves. While TG weight losses were recorded, ion intensities of mass peaksm/e=18 (water) andm/e=44 (carbon dioxide) were monitored continuously for Typhoid Vaccine U.S.P., Meningococcal Polysaccharide Vaccine Groups A and C Combined and Honey Bee Venom Allergenic Extract. MS ion intensities indicated the difference between evolution of residual moisture and moisture associated with product thermal decomposition. Residual moisture values calculated from TG weight losses indicated by mass spectral data agreed with Karl Fischer moisture data.