Pharmaceutical Analysis

Method for the analysis of residual solvents in pharmaceuticals

This application note describes a method for the analysis of Class 2 solvents (water-soluble samples) that are unsuited to Headspace GC methods.

Perform high-speed analysis of linezolid

This application note describes the high-speed analysis of linezolid following the draft guidance of International Harmonization of Pharmacopoeias.

Comprehensive cell culture profiling using Q-TOF MS/MS

This application note will help you readily perform comprehensive targeted analysis of cell culture media and understand how to identify and quantify unknown cell culture media components with high accuracy using Q-TOF MS/MS.

Effective API analysis using UHPLC-UV and a single quadrupole mass detector

This application note demonstrates how the combination of UV and a single quadrupole mass detector is a powerful tool for (active pharmaceutical ingredient) API analysis in early stages of development, enabling confirmation of expected impurities.

Learn how to conduct structural analysis of impurities in pharmaceuticals

This application note will help you understand how trap-free 2D LC-MS allows online conversion of non-volatile to volatile mobile phase conditions and how the LCMS-9030’s high mass accuracy can be used to conduct structural analysis of impurities.

Detection in Capillary Electrophoresis (CE)

This article discusses the most popular detection principles in use in industry and CE-related good working practice.

Principles of HPLC Validation - Training Module 5: Data Analysis

A short course in the systematic validation of HPLC methods. This section covers various aspects of data analysis including how and when external standardization, internal standardization, and the method of standard additions should be used for...

Improve your bioprocessing applications for the purification of biomolecules

Tosoh Bioscience has produced Volume 1 of its 'Bioprocessing Application Notebook' that comprises over twenty application notes covering important aspects of biopharmaceutical purification.

Injection Precision and Sensitivity in Capillary Electrophoresis (CE)

We discussed the significance of a constant electro-osmotic flow and good capillary conditioning for precision in our CE methods. Now we look at the importance of injection settings for precision. We will also have a first look at sample stacking...

Principles of HPLC Validation - Training Module 4: Quality by Design and Robustness

A short course in the systematic validation of HPLC methods. We introduce Quality by Design (QbD) as a laboratory lifestyle described in ICH Q8. QbD translates into more efficient method development, easier validation, more manageable methods in...

Your route to successful characterization of biopharmaceuticals

OPEN-ACCESS HPLC TRAINING TUTORIALS FROM KEY EXPERTS 

Although “small molecule” and “biomolecular” separations have traditionally been considered as separate activities, analysts in the biopharmaceutical industry regularly have to deal with both....

Methods and applications in biopharmaceutical characterization eBook

Are you looking for solutions to your biopharmaceutical workflows? Struggling with your intact protein analysis, or need help with glycosylation studies? If so Separation Science, in collaboration with Thermo Fisher Scientific, has developed an...

Capillary Conditioning — The Foundation of Precision in capillary electrophoresis (CE)

In previous issues, we saw the importance of a controlled, constant electro-osmotic flow (EOF) for proper precision. In this issue, we will therefore look into the different strategies for capillary conditioning, as a good conditioning procedure is...

Certified reference materials in solution for quantitative NMR

In recent years, quantitative NMR (qNMR) has become widely accepted as a very efficient and precise method for the quantification of organic compounds and is increasingly used in the pharmaceutical and chemical industry. Its main advantage, when...

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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