Pharmaceutical Analysis

In this article, from Issue 12 of the Analytix Reporter, produced by Merck, difluoroacetic acid (DFA) is discussed as a suitable alternative to TFA and FA for LC-UV/MS analysis.

In this article, from Issue 12 of the Analytix Reporter, produced by Merck, an LC-UV/MS method is presented using a corresponding E&L certified reference material (CRM) mix for the LC determination of extractables and leachables.

In this article, from Issue 12 of the Analytix Reporter, produced by Merck, three step-by-step protocols to monitor critical quality attributes (CQAs) of monoclonal antibodies were developed using adalimumab as an example.

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...

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...

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...

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...

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.

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.

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...