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WHO (2006) Recommendations for the Preparation, Characterization and Establishment of International and Other Biological Reference Standards (Revised 2004). WHO Technical Report Series 932, Annex 2, 73-131.

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• TITLE: Use of Thermogravimetric Analysis for Moisture Determination in Difficult Lyophilized Biological Samples

  AUTHORS: Paul Matejtschuk, Chinwe Duru, Kiran Malik, Ernest Ezeajughi, Elaine Gray, Sanj Raut, Fatme Mawas

  KEYWORDS: Thermogravimetric Analysis, Freeze Dried, Moisture Determination, Karl Fischer Titration

  JOURNAL NAME: American Journal of Analytical Chemistry, Vol.7 No.3, March 15, 2016

  ABSTRACT: Residual moisture is a key quality control parameter for lyophilized biologicals, as high moisture can correlate with poor stability. Coulometric Karl Fischer titration is the most widely used technology to determine residual water content; some chemicals are known to cause problems with Karl Fischer titration, but these chemicals do not usually occur in biologics. Three biological samples, of fibrinogen, heparin and Haemophilus influenza b polysaccharide, have caused particular issue in our hands by routine Karl Fischer analysis, illustrating different limitations with this method. The use of thermogravimetric analysis, with evolved gas mass spectrometric monitoring, is described here as a successful alternative for moisture analysis in these materials.