Pharmaceutical Analysis

Dexamethasone: An HPLC assay and impurity profiling following the USP

This article from Issue 9 of the Analytix Reporter, produced by Merck, provides a simple, precise, and sensitive reversed-phase high performance liquid chromatography (RP-HPLC) gradient method for establishing traceability and total...

Released N-glycan analysis of a therapeutic antibody

N-glycan analysis is critical to the characterization of therapeutic monoclonal antibodies. In this article, from Issue 9 of the Analytix Reporter, produced by Merck, a BIOshell™ Glycan HPLC column is used to analyze Cetuximab (Erbitux®) N...

New Reference Materials for Extractables & Leachables Testing

This article from Issue 10 of the Analytix Reporter, produced by Merck, introduces a series of new reference materials for E&L testing, including a toxic degradation product of Irganox 1010.

Protein Binding Determination - Comparison Study of Techniques & Devices

This article from Issue 10 of the Analytix Reporter, produced by Merck, provides a comparative study between the Supel™ BioSPME 96-Pin device and the rapid equilibrium dialysis technique.

Analysis of Fingolimod Hydrochloride According to USP Monograph Guidelines

This article from Issue 10 of the Analytix Reporter, produced by Merck, demonstrates a rapid, accurate, and simple method that was developed for the total chromatographic purity analysis of Fingolimod hydrochloride by HPLC-DAD, well within the...

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