Pharmaceutical Analysis

(U)HPLC Analysis of Biopharmaceuticals: Quality Attributes and How to Analyse Them

Join Separation Science and Tosoh Bioscience for a tutorial series designed to improve your (U)HPLC analysis of biotherapeutics.

Difluoroacetic Acid as an Effective Mobile Phase Modifier for the LC-UV/MS Analysis of Proteins

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.

Extractables Study with LC-UV/MS

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.

Three Methods for Critical Quality Attribute Determination of Monoclonal Antibodies

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.

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...

Applications to Improve Your Biopharmaceutical Analyses

Separation Science, in collaboration with Thermo Fisher Scientific, offers a selection of application notes relevant for biopharmaceutical analysis. Discover the latest advances in high-resolution accurate-mass (HRAM) mass spectrometry. Learn more...

Advanced Methods for Biomolecule Analysis

Separation Science, in collaboration with Agilent, offers an eBook covering advanced methods for the analysis of biomolecules, including monoclonal antibodies and biotherapeutics. Glycan and glycosylation analysis, charge variant analysis and...

How to analyse peptone samples using 2D–LC

This application from Agilent describes the 2D-LC analysis of complex peptones. Active solvent modulation proved to be valuable to maintain chromatographic performance and avoid breakthrough in the second dimension.

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