Shelf-life tests

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Chapter: Pharmaceutical Drugs and Dosage: Capsules

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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