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The determination of residual moisture in several freeze-dried vaccines and a Honey Bee Venom Allergenic Extract by TG/MS

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Abstract

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.

Zusammenfassung

Thermogravimetrie/Massenspektrometrie wurde zur Identifizierung von TG-Effekten herangezogen, die auf die Abgabe des Restwassers von gefriergetrockneten biologischen Produkten zurückzuführen sind. Für Thyphoid Vaccine U.S.P., Meningococcal Polysaccharide Vaccine Groups A and B combined und Honey Bee Venom allergenic extract wurden gleichzeitig mit der thermogravimetrischen Registrierung des Gewichtsverlustes die Ionenintensitäten der Massenpeaksm/e=18 (Wasser) undm/e=44 (Kohlendioxid) kontinuierlich verfolgt. Der Verlauf der Ionenintensität ermöglicht eine Unterscheidung zwischen Restwasser und dem bei der thermischen Zersetzung des Produktes entstehenden Wasser. Der massenspektrometrisch als solcher erkannte und auf Grund der TG-Kurve quantifizierte Restwassergehalt stimmt mit dem Wert der nach Karl Fischer bestimmten Feuchtigkeit überein.

Резюме

Термогравиметрия и м асс-спектрометрия бы ли использованы для иде нтификации ТГ переходов, соответст вующих потере остато чной влаги в биологических вещес твах, высушенных путем вымораживания. Одновременно с регис трацией потери веса, на монито рную систему выводились ионные ин тенсивности масс-пик овm/e=18 (вода) иm/e=44 (двуокись углеро да). Mace-спектрометрические данные ионных интенс ивностей показали различные м ежду выделением остаточной влаги и вл агой, выделяющейся в результате термичес кого разложения. Знач ения остаточной влаги, выч исленные из ТГ кривых потери веса и установленные на ос нове масс-спектромет рических данных, согласуются с данными, установленными по ме тоду Карла Фишера.

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Authors and Affiliations

  1. 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

    J. C. May, R. M. Wheeler & E. Grim

Authors
  1. J. C. May
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  2. R. M. Wheeler
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  3. E. Grim
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Additional information

The authors thank Jen Chiu, Ph.D. of E. I. DuPont de Nemours and Company, Wilmington, Delaware, U.S.A. for collecting TG/MS data under contract.

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May, J.C., Wheeler, R.M. & Grim, E. The determination of residual moisture in several freeze-dried vaccines and a Honey Bee Venom Allergenic Extract by TG/MS. Journal of Thermal Analysis 31, 643–651 (1986). https://doi.org/10.1007/BF01914242

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  • DOI: https://doi.org/10.1007/BF01914242

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