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The results generated at the earlier time points are the most significant because they have the highest potential for variation between the manual and automated methods.

If comparable results are obtained between the two methods at the earlier time points, a dissolution chemist is more likely to be assured that accurate data are obtained at all time points of the automated dissolution-profile testing.

Once these initial parameters have been established, a dissolution chemist can use the automated instrumentation to quickly screen early formulations and help formulators direct their future formulation efforts.

As the life cycle of the product progresses, automated dissolution-method parameters must be validated if the generated data have the potential to be included in any type of GMP submission.

Selecting the various dissolution media that are used in the evaluation depends upon the solubility and stability of the API in each media.

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