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TG/MS capillary interface

Applications to determination of residual moisture in BCG vaccine and other freeze-dried biological products

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Abstract

A TA Instruments Thermal Analysis System (TG) has been interfaced to the Hewlett Packard 5972 quadrupole mass spectrometer. An OSS-2 variable outlet splitter was plumbed between the TG and the mass spectrometer. This interface allows continuous monitoring of the ion intensities of mass peaksm/e=18 (water) andm/e=44 (carbon dioxide) used to elucidate the TG transitions attributable to residual moisture in freeze-dried biological products. Moisture specifications must be met in order 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 results are compared.

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Authors and Affiliations

  1. Center for Biologics Evaluation and Research, Food and Drug Administration, 8800 Rockville Pike, 20892, Bethesda, MD, USA

    J. C. May, A. V. Del Grosso, R. M. Wheeler & N. M. Etz

Authors
  1. J. C. May
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  2. A. V. Del Grosso
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  3. R. M. Wheeler
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  4. N. M. Etz
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May, J.C., Del Grosso, A.V., Wheeler, R.M. et al. TG/MS capillary interface. Journal of Thermal Analysis 49, 929–936 (1997). https://doi.org/10.1007/BF01996778

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  • DOI: https://doi.org/10.1007/BF01996778

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