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Forced Degradation (1) HPLC (8) ICH (17) Lifecycle (11) Method development (3) Methods (1) MHRA (1) MTS (7) MTS Helpdesk (14) OOS/OOT (2) Procedures (1) Stability (3) Troubleshooting (1) Validation (19) Verification (1) Video (4) Webinar (2)
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HPLC Mobile Phase Expiry Dates
MTS HELPDESK: What is the typical (the industrial ‘norm’) for the expiration date of mobile phases for HPLC, i.e. with buffer and without buffer. Also, what should you do (e.g., measure the pH or run and verify the retention time) if you need to extend the expiration date in extenuating circumstance e.g. shortage of acetonitrile…
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Replicates in Analytical Methods: When and How Many?
The use of replicates in analytical procedures is commonplace but it is important to understand why you are doing it and also what the results are telling you.
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How Much Forced Degradation in a Stress Study?
When I forcibly degrade my drug or drug product to create degradation products, how much degradation should I aim for?
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HPLC Autosampler Vials: Dos and Don’ts
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 some of the more common pitfalls.
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Do I Have to Revalidate a Method if the HPLC Column is Changed?
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?
Forced Degradation (1) HPLC (8) ICH (17) Lifecycle (11) Method development (3) Methods (1) MHRA (1) MTS (7) MTS Helpdesk (14) OOS/OOT (2) Procedures (1) Stability (3) Troubleshooting (1) Validation (19) Verification (1) Video (4) Webinar (2)