TG MS CAPILLARY INTERFACE - APPLICATIONS TO DETERMINATION OF RESIDUALMOISTURE IN BCG VACCINE AND OTHER FREEZE-DRIED BIOLOGICAL PRODUCTS/

A TA Instruments Thermal Analysis System (TG) has been interfaced to t he Hewlett Packard 5972 quadrupole mass spectrometer. An OSS-2 variabl e outlet splitter was plumbed between the TG and the mass spectrometer . This interface allows continuous monitoring of the ion intensities o f mass peaks m/e = 18 (water) and m/e = 44 (carbon dioxide) used to el ucidate the TG transitions attributable to residual moisture in freeze -dried biological products. Moisture specifications must be met in ord er to insure product stability throughout the approved shelf life. TG/ MS results are discussed for BCG Vaccine, BCG Live (Intravesical) and U.S. Standard Antihemophilic Factor. Karl Fischer and TG/MS moisture r esults are compared.