TYPICAL INDEX

DRUG MASTER FILE (OPEN PART)

       INTRODUCTION

1.1         Active Agents 

1.2         Scientific Data

1.2.1     Nomenclature

1.2.2     Description

1.2.3     Production

1.2.4     Quality control during manufacture starting material

1.2.5     Quality control during manufacture packing material

1.2.6     Quality control during manufacture General Tests

1.2.7     Controls on the intermediates

1.2.8     Chemical development of product

1.2.8.1        IR Spectrum

1.2.8.2        Certificate of Analysis

STABILITY DATA.