Pharmaceutical Analysis

Separation Science in collaboration with the life science business of Merck KGaA, Darmstadt, Germany

Recent Posts

Nitrosamine Testing using LC-MS Methods from the USP General Chapter <1469>

This article from Issue 14 of the Analytix Reporter shows intriguing findings from work with USP Chapter <1469>, Procedure 1, and a successful implementation of Procedure 3 where all system method suitability requirements were met.

Analysis of Nucleotide Activated Sugars by LC-MS/MS

This article from Issue 14 of the Analytix Reporter reveals a sensitive quantitative LC-MS/MS method under reversed phase (RP) conditions using a Supel™ Carbon LC column. This was developed for the simultaneous analysis of eleven highly polar...

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 Oligonucleotides by SEC-MALS

This article from Issue 13 of the Analytix Reporter demonstrates the ability of TSKgel® UP-SW2000 size exclusion chromatography (SEC) columns to distinguish between oligonucleotide species differing by one base in length. To further analyse...

Synthetic Carbon Adsorbents for Removal of Host Cell Proteins in Monoclonal Antibody Purification

The removal of host cell proteins (HCPs) in the manufacturing of mAbs remains a challenge. This article, from Issue 13 of the Analytix Reporter, teaches you how to improve depletion of difficult-to-remove lower molecular weight and hydrophobic HCPs...

Fast Analysis of Intact Therapeutic Monoclonal Antibody Trastuzumab

This article, from Issue 13 of the Analytix Reporter, demonstrates a high-resolution and reproducible analysis of mAb trastuzumab in less than 5 minutes using a BIOshell™ A400 Protein C4 column. More importantly the optimized method was able to...

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...

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.

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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