Good Pharmacopoeial Practices: Chapter On Monographs

Good Pharmacopoeial Practices: Chapter on monographs for compounded preparations

Annex 6

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

Good Pharmacopoeial Practices: Chapter On Monographs