Journal of thermal analysis

, Volume 37, Issue 9, pp 2031–2065 | Cite as

A basic strategy for the thermal stability assessment of pharmaceutical synthetic intermediates and products

  • Ian Townsend


A relatively simple strategy is described for the thermal hazard screening of isolated synthetic intermediates and products, as employed within the Research Division of a major pharmaceutical company.

Differential scanning calorimetry under carefully controlled conditions is used as a screening technique to reveal any propensity a material may have towards significant exothermic decomposition. Suspect samples are further investigated via combustion tests, such as train firing studies or flash point determinations, and via accelerating rate calorimetry; data obtained facilitate characterisation with regard to ignition/flammability properties and bulk stability. A real-life case study is presented to illustrate the application of this methodology to an unstable synthetic intermediate for which safe conditions for processing and bulk storage are derived.


Differential Scanning Calorimetry Combustion Test Exothermic Decomposition Thermal Hazard Synthetic Intermediate 
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Es wird eine relativ einfache Methode zur Ermittlung der WÄrmeempfindlichkeit isolierter synthetischer Zwischenprodukte und Endprodukte beschrieben, wie sie innerhalb eines gro\en Arzneimittelunternehmens vorkommen. Als Screening-Verfahren wurde DSC unter sorgfÄltig kontrollierten Bedingungen angewendet, um jegliche Neigungen festzustellen, die eine Substanz bezüglich einer signifikanten exothermen Zersetzung haben kann. VerdÄchtige Proben wurden weiterhin mittels Verbrennungstests und ARC untersucht; die ermittelten Angaben erleichtern die Charakterisierung im Hinblick auf Entzündungs- und Entflammbarkeitseigenschaften sowie MassebestÄndigkeit. Es wird weiterhin eine in der Praxis durchgeführte Studie beschrieben, um die Anwendung dieses Verfahrens bei einem unbestÄndigen synthetischen Zwischenprodukt zu illustrieren, für welches sichere Verfahrens- und Lagerungsbedingungen ermittelt wurden.


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Copyright information

© Wiley Heyden Ltd, Chichester and Akadémiai Kiadó 1991

Authors and Affiliations

  • Ian Townsend
    • 1
  1. 1.Smithkline Beecham PharmaceuticalsWorthingUK

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