Transcription of USP Guideline for Submitting Requests for Revision …
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USP Guideline for Submitting Requests for Revision …
USP Guideline for Submitting Requests for Revision to USP NF Submission Guideline for Chemical Medicines Page 1 of 21 EFFECTIVE DATE 04/29/2016 TABLE OF CONTENTS A. INTRODUCTION 1. General Information 2. Submitting a Request for Revision Purpose General requirements and considerations 3. What to Expect After Submission Process Briefing Approximate timeline 4. Flexible Monographs Purpose Additional procedures Alternate acceptance criteria Labeling requirements B. MONOGRAPH CONTENT 1. Name Drug substance Drug product 2. Description (Chemical Information) Information to include Drug substance forms CAS number 3. Definition Drug substance Drug product 4. Identification Infrared spectroscopy Ultraviolet spectroscopy Liquid chromatography or gas chromatography Thin-layer chromatography Tests for salts and counter-ions Melting range USP Guideline for Submitting Requests for Revision to USP NF Submission Guideline for Chemical Medicines Page 2 of 21 EFFECTIVE DATE 04/29/2016 X-ray diffraction tests Other 5.
Additional Requirements. 9.1 Packaging and storage . 9.2 Labeling . 9.3 Reference Standards . C. OTHER INFORMATION. 1. Reagents. 2. Chromatographic Columns
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