Authors:
J. May Center for Biologics Evaluation and Research, Food and Drug Administration, 8800 Rockville Pike, 20892 Bethesda, MD USA

Search for other papers by J. May in
Current site
Google Scholar
PubMed
Close
,
A. Del Grosso Center for Biologics Evaluation and Research, Food and Drug Administration, 8800 Rockville Pike, 20892 Bethesda, MD USA

Search for other papers by A. Del Grosso in
Current site
Google Scholar
PubMed
Close
,
R. Wheeler Center for Biologics Evaluation and Research, Food and Drug Administration, 8800 Rockville Pike, 20892 Bethesda, MD USA

Search for other papers by R. Wheeler in
Current site
Google Scholar
PubMed
Close
, and
N. Etz Center for Biologics Evaluation and Research, Food and Drug Administration, 8800 Rockville Pike, 20892 Bethesda, MD USA

Search for other papers by N. Etz in
Current site
Google Scholar
PubMed
Close
Restricted access

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.

  • Collapse
  • Expand

To see the editorial board, please visit the website of Springer Nature.

Manuscript Submission: HERE

For subscription options, please visit the website of Springer Nature.

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)

Monthly Content Usage

Abstract Views Full Text Views PDF Downloads
Sep 2024 19 0 0
Oct 2024 65 0 0
Nov 2024 13 0 0
Dec 2024 23 0 0
Jan 2025 17 0 0
Feb 2025 23 0 0
Mar 2025 0 0 0