The Determination of Product Expiry Dates from Short Term Storage at Room Temperature
- 1 January 1974
- journal article
- research article
- Published by Taylor & Francis in Drug Development Communications
- Vol. 1 (3) , 185-210
- https://doi.org/10.3109/03639047409088175
Abstract
Increasingly registration authorities are requesting expiry dating of pharmaceuticals. A scheme is suggested based on short term stability data at “room temperature” for obtaining reliable expiry dates. The advantages and disadvantages of this method and methods using elevated temperatures and the Arrhenius plot are discussed. The statistical equations necessary to calculate the minimum predicted shelf life are given and difficulties encountered in their use explained.Keywords
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