The MTS consultant, Oona McPolin, will deliver a presentation entitled, ‘Challenges in Development and Validation of Stability Indicating Methodology‘ at the JPAG symposium, ‘Stability VI’ on the 30th June 2022, which will be held at the Royal Society of Chemistry in Burlington House, London. If you are interested in the analytical methodology used for supporting […]
Author: MTS
Limit of Quantitation: Does it Matter?
Defined as “the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy” in ICH Q2(R1), limit of quantitation (or ‘quantitation limit’ in the ICH terminology) is an important method performance characteristic which is typically demonstrated during analytical method validation. Although the concept of limit of quantitation (LOQ) […]
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: […]
How Long to Equlibrate an HPLC Column?
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 is not appropriate. The amount of mobile phase which should be flushed through a column before it is ready to use is usually expressed […]
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 […]
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. […]