WHO TRS 1010, 2018 Annex 6

WHO TRS (Technical Report Series) 1010, 2018 Annex 6

Good Pharmacopoeial Practices: Chapter on monographs for compounded preparations

Click on the titles below for complete guidelines

TABLE OF CONTENTS

Background

1. Introduction

2. Monograph development

3. Quality of ingredients

4. Monograph title

5. Sections of the compounded preparation monograph

5.1 Definition and content

5.2 Assay

5.3 Compounding procedures

5.4 Identification tests

5.5 Specific tests

5.6 Additional information

5.7 Stability information and beyond-use dating for compounded preparations

WHO TRS (Technical Report Series) 1010, 2018 Annex 6