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For rapidly dissolving medicinal products containing active substances that are highly soluble throughout the physiological range, a disintegration test may be described in an individual monograph on a medicinal product. This approach is in line with the relevant guidelines applied nationally or regionally (such as the ICH Q6A guideline) and with the relevant Ph. Eur. dosage form monograph (e.g. 0478 Tablets or 0016 Capsules).

In such cases, the applicant may either select the monograph disintegration test or develop an in-house disintegration or dissolution test as the product-specific test. In all cases, the applicant has to demonstrate the suitability of the selected test to the satisfaction of the competent authority.

With respect to compliance with the monograph test, the principles applied to disintegration tests mirror those outlined for dissolution testing in the Ph. Eur. General Notices under “Dissolution/Disintegration”.






















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