Transcription of 1092 THE DISSOLUTION PROCEDURE: DEVELOPMENT AND …
{{id}} {{{paragraph}}}
Example: confidence
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).
sources of variability and interferences. During routine testing of the product, variability outside the expected range should be investigated from analytical, formulation, and processing perspectives. MEDIUM Physical and chemical data for the drug substance and dosage unit need to be determined before selecting the dissolution medium.
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: