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Forced Degradation (1) HPLC (8) ICH (11) Lifecycle (6) Method development (3) Methods (1) MTS (5) MTS Helpdesk (11) OOS/OOT (1) Procedures (1) Stability (3) Troubleshooting (1) Validation (16) Verification (1) Video (5) Webinar (2)
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Do I Have to Revalidate a Method if the HPLC Column is Changed?
MTS Helpdesk Question: 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? Answer: My preference is to develop a new…
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What is Mass Balance in a Forced Degradation Study?
MTS Helpdesk Question: 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? Answer: When used in the context of an analytical method, the term ‘mass balance’ relates to its ability to analyse the degradation products of a drug molecule.…
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Why are ‘Bio’ Test Methods so Tricky to Validate?
MTS Helpdesk Question: 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…
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A Brief Guide to HPLC Instruments
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…
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A Wish List for ICH Q2(R2), the Revision of the Guideline on Method 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…
Forced Degradation (1) HPLC (8) ICH (11) Lifecycle (6) Method development (3) Methods (1) MTS (5) MTS Helpdesk (11) OOS/OOT (1) Procedures (1) Stability (3) Troubleshooting (1) Validation (16) Verification (1) Video (5) Webinar (2)