Paul Wrezel

The removal of azide as a potential impurity from a drug substance may be critical to its safety profile. The quantitation of this impurity is an important control parameter. This article describes a simple and practical assay for azide using chemical derivatization and HPLC. The method is shown to be suitable for the intended purpose on three example test materials. Potential issues for wider applications are discussed.

The removal of azide as a potential impurity from a drug substance may be critical to its safety profile. The quantitation of thi impurity is an important control parameter. This article describes a simple and practical assay for azide using chemical derivatization and HPLC.

A simple and practical assay for azide using chemical derivatization and high performance liquid chromatography.

Supercritical Fluid Chromatography (SFC) is quickly becoming a popular choice by chromatographers for analytical and preparative separations.

Supercritical Fluid Chromatography (SFC) is quickly becoming a popular choice by chromatographers for analytical and preparative separations.

Measurement of chiral purity is a necessary means of quality control for drug substances that exhibit chiral centers. This article describes a simple and practical approach to setting up system suitability and validation for chiral purity assays.

The authors explain why sample diluent is more than just a solubilizing agent and describe a systematic process for diluent selection when developing an HPLC assay of an active pharmaceeutical ingredient.

The authors describe a sensible approach for validation and implementation of HPLC IPC assays.