Journal of Thermal Analysis and Calorimetry
Volume/Issue:
Volume 68: Issue 2
Applications of Thermal Analysis and Coupled Techniques in Pharmaceutical Industry
Author:
D. Giron Novartis Pharma Chemical and Analytical Research and Development Basel Switzerland

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Pages:
335–357
Online Publication Date:
03 Nov 2004
Publication Date:
01 May 2002
Article Category:
Research Article
DOI:
https://doi.org/10.1023/a:1016015113795
Keywords:
amorphous state; cGMP; DSC-TG; DSC-X-ray diffraction; ICH; ICHQ6; microcalorimetry; pharmaceutical industry; pharmaceuticalpolymers; phase transitions; phase-diagrams; polymorphism; sorption-desorption; pseudo-polymorphism; purity analysis; TG-FT-IR; TG-MS; thermal analysis coupled techniques; validation of methods
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Abstract  

Thermal analysis methods are well-established techniques in research laboratories of pharmaceutical industry. The robustness and sensitivity of instrumentation, the introduction of automation and of reliable software according to the industrial needs widened considerably the areas of applications in the last decade. Calibration of instruments and validation of results follow the state of the art of cGMP as for other analytical techniques. Thermal analysis techniques are especially useful for the study of the behavior of the poly-phasic systems drug substances and excipients and find a unique place for new delivery systems. Since change of temperature and moisture occur by processing and storage, changes of the solid state may have a considerable effect on activity, toxicity and stability of compounds. Current requirements of the International Conference of Harmonisation for the characterization and the quantitation of polymorphism in new entities re-enforce the position of thermal analysis techniques. This challenging task needs the use of complementary methods. Combined techniques and microcalorimetry demonstrate their advantages. This article reviews the current use of thermal analysis and combined techniques in research and development and in production. The advantage of commercially coupled techniques to thermogravimetry is emphasized with some examples.

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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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