P.W. Wrezel | Authors

Articles

Assay for ppm Levels of Azide in Drug Substances

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.

Assay for Parts-Per-Million Levels of Azide in Drug Substances

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.

Validation and Implementation of In-Process Control HPLC Assays for Active Pharmaceutical Ingredients

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