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Forced Degradation (1) HPLC (8) ICH (10) Lifecycle (5) Method development (2) Methods (1) MTS (2) MTS Helpdesk (11) OOS/OOT (1) Procedures (1) Stability (3) Troubleshooting (1) Validation (15) Verification (1) Video (5) Webinar (2)
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How Much Forced Degradation in a Stress Study?
MTS Helpdesk Question: When I forcibly degrade my drug or drug product to create degradation products, how much degradation should I aim for? Answer: The aim of a forced degradation study is to generate degradation products from a drug which are both realistic and representative, typically for the purposes of assessing degradation pathways, or to…
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HPLC Autosampler Vials: Dos and Don’ts
MTS Helpdesk Question: Can you provide some dos and don’ts related to HPLC vials? Answer: The HPLC vial is a seemingly minor component of an HPLC system but it has the potential to create major problems. This is particularly true for quantitative analysis. The following list of dos and don’ts will help you to avoid…
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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…
Forced Degradation (1) HPLC (8) ICH (10) Lifecycle (5) Method development (2) Methods (1) MTS (2) MTS Helpdesk (11) OOS/OOT (1) Procedures (1) Stability (3) Troubleshooting (1) Validation (15) Verification (1) Video (5) Webinar (2)