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Application Note

Residual Solvents in Pharmaceuticals by USP Chapter Methodology

Introduction

The synthesis of active pharmaceutical ingredients(API) may require multiple reaction steps that produce undesirable reaction byproducts or utilize various solvents that have to be removed from the finished product. These solvents and byproducts may be measured with headspace gas chromatography for those volatile residual organic solvents according to the USP chapter 467 method.