Pharmaceutical Analysis

An Optimized Protocol for Peptide Mapping of Therapeutic Monoclonal Antibodies

Conventional protein digestion procedures used in peptide mapping are lengthy and introduce significant amounts of oxidation and deamidation artifacts. In this article, from Issue 11 of the Analytix Reporter, produced by Merck, the optimized...

Determination of N-Nitrosamines in Valsartan

The recent years have witnessed the emergence of nitrosamines as a serious contaminant group in APIs from the sartan family. In this article, from Issue 11 of the Analytix Reporter, produced by Merck, a GC-MS method to determine nitrosamines in...

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 chromatographic...

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-glycans...

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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