New Approach for Dissolution or Disintegration Tests in Ph. Eur. Monographs to be Published in Supplement 10.6.

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A new policy for dissolution and disintegration testing in European Pharmacopoeia (Ph. Eur.) monographs has been adopted at the 168th session of the European Pharmacopoeia Commission (November 2020). A dissolution or disintegration test will be included in each medicinal product monograph on an immediate-release solid dosage form. The details of the scope of such a test will be included in the General Notices (Chapter 1 of the Ph. Eur.).

According to a press release dated 10 December 2020, the following monographs have been revised:

• Deferiprone tablets (2986)
• Dronedarone tablets (3038)
• Lacosamide tablets (2989)
• Raltegravir chewable tablets (2939)
• Raltegravir tablets (2938)
• Regorafenib tablets (3023)
• Riociguat tablets (3079)
• Rivaroxaban tablets (3021)
• Rosuvastatin tablets (3008)
• Sitagliptin tablets (2927)
• Sorafenib tablets (3022)
• Ticagrelor tablets (3097)

The sentence „The tablets comply with the test and the acceptance criterion described below, unless otherwise justified and authorised“ was deleted and a footnote referring to the General Notices was added. The revised monographs and the revised General Notices will be published in Supplement 10.6. 

When a dissolution test is described in an individual monograph on a medicinal product, the applicant may either select the monograph dissolution test or develop an in-house dissolution test as the product-specific dissolution test. In any case, the applicant has to demonstrate the suitability of the selected test to the satisfaction of the competent authority. However, when tested, the medicinal product has to comply with the monograph dissolution test, unless otherwise justified by the applicant.