Pharmaceutical Analysis Blog

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...

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...

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...

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 Capillary Electrophoresis (CE) Capillary

The small diameter of the capillary in capillary electrophoresis makes for a very good heat dissipation compared with conventional electrophoresis. As a consequence, much higher voltages can be applied before heat dissipation becomes an issue. 

Principles of HPLC Validation - Training Module 2: Method Development and Pre-Validation

A short course in the systematic validation of HPLC methods. The validation process is best started with the first injection during method development. We discuss the importance of having an overall plan for the method development / validation /...

Method Development in Capillary Electrophoresis (CE): Selecting your Background Electrolyte

The selection of the proper background electrolyte (BGE) is key to a successful CE method. We first look into the choices for BGE based on our analyte properties. Capillary electrophoresis (CE) is based on migration of charged components in an...

Principles of HPLC Validation - Training Module 1: Introduction

A short course in the systematic validation of HPLC methods. We start by taking an overview of the validation process and review some of the key references that will be useful in setting up a validation process. We also discuss the terminology...

Reaction Monitoring with UltraPerformance Convergence Chromatography

Once a chemical hit is found through a library screening process and verified, the synthetic route is then optimized. This step involves an iterative process of synthesis and reactivity measurements of the new compound(s) to further develop the...

Why CE (Capillary Electrophoresis)?

The capillary electrophoresis (CE)techniques have been around since the 1980s, and commercial instruments available since the end of that decade. So why would we start on such a topic now? There are several indications for a growing interest in...

    

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