Protocol for stability testing

Stability information from accelerated and long-term testing is required to be provided on at least three batches manufactured to a minimum of pilot plant scale by the same synthetic route and using a method of manufacture and 

Rguie4.19 Logarillim of llie nitrazepam decomposition constant, k, as a function of relative humidity at various temperatures. 

Reproduced from D. Genton and U. W. Kesselring, J. Pham. ci, 66, 676 (1977) with permission. 

The long-term testing is required to be continued for a sufficient period beyond 12 months to cover all appropriate re-test periods. The frequency of testing should be 

In the case of dmg products, significant change at the accelerated condition is defined as 

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Table 1 An example of commonly used protocols for stability testing of tablet products...

In liquid formulations the shelf-life of a formulation can be estimated by application of the Arrhenius equation. The protocol for stability testing of dmg substances and dmg products has been discussed. 

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