Category: Resource Library

Do I Have to Revalidate a Method if the HPLC Column is Changed?

Post author By MTS
Post date 24 January 2022
Categories In HPLC, MTS Helpdesk, Resource Library

I would like to have a ‘back-up’ column for my HPLC method so that I am not reliant on one supplier, but how can I choose one that will be suitable and do I need to validate the method fully on the replacement column?

What is Mass Balance in a Forced Degradation Study?

Post author By MTS
Post date 17 January 2022
Categories In MTS Helpdesk, Resource Library, Stability, Validation

What is the ‘mass balance’ for an analytical method and is it critical that I investigate it as part of method development or method validation?

Why are ‘Bio’ Test Methods so Tricky to Validate?

Post author By MTS
Post date 10 January 2022
Categories In Articles, MTS Helpdesk, Resource Library, Validation, Videos

When it comes to validation, analytical test methods used for medicinal products based on biological molecules can be a bit ‘tricky’ to deal with. Coming up with a suitable design for the validation protocol can be quite difficult. In particular, the choice of what parameters to investigate, and the design of the associated experiments. What are the main reasons for this?

A Brief Guide to HPLC Instruments

Post author By MTS
Post date 10 January 2022
Categories In Articles, HPLC, Resource Library, Videos

High Performance Liquid Chromatography, or HPLC as it is commonly known, is an important analytical technique used to gain both quantitative and qualitative data for samples produced in a variety of industries such as pharmaceuticals, food products and industrial chemicals. The purpose of this video is to look at the question: ‘What is an HPLC […]

A Wish List for ICH Q2(R2), the Revision of the Guideline on Method Validation

Post author By MTS
Post date 29 October 2020
Categories In Articles, Resource Library, Validation

The ICH guideline on method validation, Q2 (R1) [1], is currently being updated and I thought it might be interesting to put together a wish list for the changes that I would like to see in the new version. Rather than a wide-ranging treatment of all analytical method validation related issues, such as how it […]

Strategies for HPLC Method Development

Post author By MTS
Post date 25 September 2020
Categories In HPLC, Resource Library, Videos, Webinar

Webinar Recording This webinar explored the different strategies, and combinations of strategies, which may be applied during HPLC method development. The best approach may vary depending on the particular requirements for a given separation. Related content from our Resources Library Services related to this content that we offer We have a number of training courses […]