Vorgaben und Durchführung von Stabilitätsprüfungen pharmazeutischer Wirkstoffe und Arzneimittel Rainer Walz und Martin Knauf UFAG Laboratorien AG, Sursee (Schweiz) Korrespondenz: Dr. Martin Knauf, UFAG Laboratorien AG, Kornfeldstrasse 4, 6210 Sursee (Switzerland), Fax +41 (0)41 926 83 40, e-mail: info@ufag-laboratorien.ch Requirements for and Performance of Stability Tests with Active Pharmaceutical Ingredients and Finished Drugs The purpose of stability studies is to investigate how a pharmaceutical product or active pharmaceutical ingredient (API) might change under certain environmental conditions (temperature, humidity, illumination) during a defined period of time. The study results are used to define the expiry date and the storage recommendations of an API or a drug. For stability studies the applied climatic conditions, the storage period, the testing intervals, the number of batches investigated and the used packaging materials depend on the development state of the drug and vary according to the climatic zones of the countries of distribution. Separate guidelines are regulating stability studies if the product or the production process are changed or if multi-dose containers are examined for in-use stability. These stability topics and additionally the fundamental requirements concerning validation of analytical procedures are discussed in the following review. Key words In-use-Stabilitätsprüfung • Stabilitätsprüfung • Validierung |
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pharmind 2008, Nr. 9, Seite 1135
