Transcription of 1092 THE DISSOLUTION PROCEDURE: DEVELOPMENT AND …
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1092 THE DISSOLUTION PROCEDURE: DEVELOPMENT AND …
BRIEFING 1092 The DISSOLUTION Procedure: DEVELOPMENT and Validation, USP 36 page 735. This general information chapter is proposed for revision by the General Chapters Dosage Forms Expert Committee. The proposed chapter content replaces the entire current chapter. The proposed changes are discussed in a Stimuli to the Revision Process article published in this issue of PF. Additionally, minor editorial changes have been made to update the chapter to current USP style. Comment deadline: March 31, 2014 (GCDF: W. Brown.) Correspondence Number C133022 1092 THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION Change to read: The USP DISSOLUTION procedure is a performance test applicable to many dosage forms. It is one test in a series of tests that constitute the dosage form's public specification (tests, procedures for the tests, acceptance criteria). To satisfy the performance test, USP provides the general test chapters Disintegration 701, DISSOLUTION 711, and Drug Release 724.
The dissolution characteristics of an oral formulation should be evaluated in the physiologic pH range of 1.2 to 6.8 (1.2 to 7.5 for modified-release formulations). During method development, it may be useful to measure the pH before and after a run to discover whether the pH changes during the test. Selection of the most appropriate
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