Shelf-life tests
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Stability testing of capsules is performed to determine the physicochemical stability of the active drug molecule in the finished drug product under specified package and recommended storage conditions.
Shelf-life tests
Stability
testing of capsules is performed to determine the physicochemical stability of
the active drug molecule in the finished drug product under specified package
and recommended storage conditions. Shelf-life tests are usually same as the
finished product tests. Since the shelf life of the prod-uct at recommended
storage conditions can be long, the product is often subjected to accelerated
(higher than normal levels of environmental con-ditions) storage for predicting
shelf life under recommended storage con-ditions. These storage conditions that
are accelerated for stability testing include temperature, humidity, and light.
For
example, for a product intended for sale in the United States with recommended
storage at room temperature and ambient humidity, real-time stability is
carried out at 25°C and 60% relative humidity (RH) with periodic testing up to
the recommended shelf life, for example, 2 years. Accelerated stability testing
on such a product is usually carried out at 40°C and 75% RH for a limited
duration of time, for example, 3 months. The exact conditions for real-time and
accelerated storage testing depend on the geographic and climatic region where
the drug product is intended to be manufactured and marketed.
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