Pharmaceutical Analysis Blog

Detection in Capillary Electrophoresis (CE)

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...

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...

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...

Principles of HPLC Validation - Training Module 3: Validation and Documentation

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...

The importance of particle pore diameter for biomacromolecule separations

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...

Headspace GC method for residual solvents analysis in pharmaceutical products

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...

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