Transcription of OFFICIAL, EFFECTIVE DATE 11/04/2021
{{id}} {{{paragraph}}}
USP Guideline for Submitting Requests for Revision to USP NF Submission Guideline for Excipients Page 1 of 26 EFFECTIVE DATE 04/29/2016 TABLE OF CONTENTS A. INTRODUCTION 1. General Information 2. Submitting a Request for Revision Purpose General requirements and considerations Format Specific tests 3. What to Expect After Submission Process Briefing Approximate timeline B. MONOGRAPH CONTENT 1. Name 2. Description (Chemical Information) Structure Molecular formula Molecular weight CAS number Chemical names 3. Definition 4. Identification Infrared spectroscopy Ultraviolet spectroscopy Liquid chromatography or gas chromatography Thin-layer chromatography Identification of specific salts Other 5.
• Sponsors should be familiar with the General Information for All Submissions. Sponsors also should be familiar with the General Notices and Requirements ... USP Guideline for Donors of USP Reference Standard Candidate Materials . available on USP.org. OFFICIAL, EFFECTIVE DATE 11/04/2021.
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document:
{{id}} {{{paragraph}}}