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Forced Degradation (1) HPLC (8) ICH (10) Lifecycle (5) Method development (2) Methods (1) MTS (1) MTS Helpdesk (11) OOS/OOT (1) Procedures (1) Stability (3) Troubleshooting (1) Validation (15) Verification (1) Video (5) Webinar (2)
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Drafts of ICH Q2(R2) and Q14 on Public Consultation
Draft versions of the revision of ICH Q2, Validation of Analytical Procedures, and also the new guideline Q14, Analytical Procedure Development, were published on the 24th March 2022. The deadline for comments is 31st July 2022. You can view the draft guidelines, and also a presentation from ICH about the guidelines, using the following links:…
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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…
Forced Degradation (1) HPLC (8) ICH (10) Lifecycle (5) Method development (2) Methods (1) MTS (1) MTS Helpdesk (11) OOS/OOT (1) Procedures (1) Stability (3) Troubleshooting (1) Validation (15) Verification (1) Video (5) Webinar (2)