MTS HELPDESK:
Is the limit of quantitation always important when validating methods for impurities?
Category: Resource Library
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?
MTS HELPDESK:
How long does it take to equilibrate a column on an HPLC system before the first injection can be performed?
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 or delay of the orders from the vendor, etc.?
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.
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?