Pharmaceutical Analysis Blog

[eBook] Pharmaceutical and biopharmaceutical solutions

This eBook contains a selection of application notes relevant for pharmaceutical and biopharmaceutical analysis using HPLC / (U)HPLC or LC-MS/MS.

Broughton Nicotine Services accelerating science through innovation

This case study describes how Broughton Nicotine Services, a Contract Research Organization (CRO) utilizes a number of state-of-the-art technologies able to meet the analytical needs of their clients including Vanquish UHPLC platforms coupled to...

How to Select a Reproducible Starting Point in HPLC Method Development

Separation Science, in collaboration with Phenomenex offers an on-demand webinar 'HPLC/UHPLC Reversed-Phase Method Development: Selecting a Reproducible Starting Point' with pharma industry expert, Dr Phil Koerner.

Achieve simultaneous analysis of monoclonal antibodies using Dual LC

This application note will teach you how to perform simple and rapid high-throughput analysis of biotherapeutics using different chromatographic techniques at one time.

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.

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...

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...

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...

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 /...

Updating HPLC compendial methods for improved pharmaceutical analysis

Would you like to learn more about the vital role of compendial methods in pharmaceutical analysis and how, by making adjustments to them, laboratory efficiency can be increased and cost decreased? If so, this on-demand webinar will provide the...

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...

    

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