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  • 1 Analytical R and D, Chemical Development, Sandoz Pharma, Basel, Switzerland
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Several drug substances or excipients are hygroscopic. The uptake or loss of water of such substances is generally difficult to control during processing or storage of drug products. DSC instruments with sub-ambient temperature equipment allow the determination of the amount of freezable water by measuring the corresponding melting enthalpy. The determination of freezable water adds valuable information complementary to TG analysis for understanding the processing and storage of raw materials and drug products. Several substances were tested as is, without treatment, after storage at 92% r.h. and after equilibration with water. The results of these experiments showed that it was possible to demonstrate defined hydrate formation, to determine the upper level of binding of water in amorphous substances and to confirm reversible hydrate formations demonstrated by temperature resolved X-ray diffraction.

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

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