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Forced Degradation (1) HPLC (7) ICH (9) Lifecycle (4) Method development (1) Methods (1) MTS (2) MTS Helpdesk (4) OOS/OOT (1) Procedures (1) Stability (3) Troubleshooting (1) Validation (13) Video (4) Webinar (2)
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HPLC Mobile Phase Expiry Dates
Question: 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 or…
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Replicates in Analytical Methods: When and How Many?
Do you prepare your samples/standards in duplicate without really thinking about it? If challenged on why, would your answer be something like, “it’s good practice, isn’t it?” 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?
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 create suitable…
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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. Do: Choose your vial carefully There are many different…
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Need to Revalidate Method if HPLC Column is Changed?
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 HPLC method…
Forced Degradation (1) HPLC (7) ICH (9) Lifecycle (4) Method development (1) Methods (1) MTS (2) MTS Helpdesk (4) OOS/OOT (1) Procedures (1) Stability (3) Troubleshooting (1) Validation (13) Video (4) Webinar (2)