Journal of Thermal Analysis and Calorimetry
Volume/Issue:
Volume 83: Issue 1
Thermogravimetry and vapor pressure moisture Applications to determination of residual moisture in BCG vaccine
Authors: J May 1 , A Del Grosso 1 , N Etz 1 , R Wheeler 1 , and L Rey 2
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  • 1 Center for Biologics Evaluation and Research, FDA, Rockville USA 20852 MD 1401 Rockville Pike Rockville USA 20852 MD 1401 Rockville Pike
  • | 2 Conseiller Scientifique Lausanne Switzerland CH-1010 Chemin de Verdonnet 2 Lausanne Switzerland CH-1010 Chemin de Verdonnet 2
Pages:
31–33
Online Publication Date:
10 Mar 2006
Publication Date:
08 Jan 2006
Article Category:
Research Article
DOI:
https://doi.org/10.1007/s10973-005-7052-6
Keywords:
BCG vaccine; lyophilization; residual moisture; thermogravimetry
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Abstract  

Thermogravimetry (TG), thermogravimetry/mass spectrometry (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 licensed product's 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 α-interferon and BCG vaccine. Impact of residual moisture and vapor pressure moisture upon product stability is presented.

Cover Journal of Thermal Analysis and Calorimetry
Journal of Thermal Analysis and Calorimetry
Print ISSN:
1388-6150
Online ISSN:
1572-8943

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Journal of Thermal Analysis and Calorimetry
Language English
Size A4
Year of
Foundation		 1969
Volumes
per Year		 1
Issues
per Year		 24
Founder Akadémiai Kiadó
Founder's
Address		 H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Publisher Akadémiai Kiadó
Springer Nature Switzerland AG
Publisher's
Address		 H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
CH-6330 Cham, Switzerland Gewerbestrasse 11.
Responsible
Publisher		 Chief Executive Officer, Akadémiai Kiadó
ISSN 1388-6150 (Print)
ISSN 1588-2926 (Online)

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