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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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How Long to Equlibrate an HPLC Column?
MTS Helpdesk Question: How long does it take to equilibrate a column on an HPLC system before the first injection can be performed? Answer: This is a question commonly asked by HPLC analysts, particularly those relatively new to the technique. The range of currently available column dimensions means that a ‘one size fits all’ approach…
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HPLC Mobile Phase Expiry Dates
MTS Helpdesk 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…
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Replicates in Analytical Methods: When and How Many?
MTS Helpdesk Question: What is the purpose of preparing replicates in analytical methods? Answer: 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…
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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…
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)