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Answer:

The principles applied to disintegration mirror those applied to dissolution in the General Notices.

Where appropriate, If a disintegration test is described in an individual monograph on a medicinal product monograph, a suitable . In such cases, the applicant may either select the monograph disintegration test or develop an in-house disintegration test as the product-specific test has to be proposed by the applicant for routine quality control to confirm batch-to-batch consistency. This test must be described in the MAA for submission to the competent authority. The demonstration of the suitability of the test has to be made by the applicant to the disintegration test. In any case, the applicant has to demonstrate the suitability of the selected test to the satisfaction of the competent authority, as is already the case for a dissolution test.