Pharmaceutical Analysis Blog

We went through the fundamentals, the separation medium BGE, the capillary and injection in capillary electrophoresis. In this article of CE Solutions we will reach the end of the system, the detector. We will discuss the most popular detection...

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...

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

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...

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...

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...

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...

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...

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...

A short course in the systematic validation of HPLC methods. We go through the various validation steps in detail. We review the key regulatory requirements from the International Committee on Harmonization (ICH), which also apply to the national...

Recently, the evolution of middle to large biomacromolecules such as peptides or proteins is apparent in the market of pharmaceutical drugs in addition to traditional active ingredients based on small molecules. The use of peptides for clinical...

The aim of this study was to develop a rapid, cost-effective, modified USP <467> HS-GC-FID method for residual solvent determination in pharmaceutical products using the Thermo Scientific™ TriPlus™ 500 Headspace Autosampler and nitrogen as...