Sequentiell-isothermer Stabilitätstest (SIST) als effizientes Screening-Modell für die Stabilitätsprüfung von Substanzen
Armin Wolff und Robert Kowitz
Hochschule Albstadt-Sigmaringen, Sigmaringen
Korrespondenz: Prof. Dr. Armin Wolff, Hochschule Albstadt-Sigmaringen, Anton-Günther-Str. 51, 72488 Sigmaringen (Germany), Fax +49 (0)7571-732 250, e-mail: wolff@hs-albsig.de Sequential Isothermal Stability Test (SIST) as Screening Model for the Stability Screening of Substances
For the screening of stability in the early stage of the development of pharmaceuticals a sequential isothermal stability test (SIST) is proposed using minimum amounts of substance, analytical tests and time. One single sample of the substance to be tested passes through each of the provided test conditions. The degradation rate in each of the test conditions should be about 10 %, but for all of the test conditions not more than 50 %. The minimum amount of substance is calculated from the limit of quantitation of the analytical method and the test schedule. By using an active calculation table, rate constants, order of reaction and activation enthalpy are immediately calculated. Thus the storage conditions and times of storage can be modified during the test is going on. Key words Sequentiell-isothermer Stabilitätstest • Wirkstoffe, Haltbarkeit, Reaktionskinetik |
