MTS HELPDESK:
What are the elements of the Analytical Procedure Lifecycle, as mentioned in guidance documents such as ICH Q14 and USP <1220>?
Category: MTS Helpdesk
Limit of Quantitation: Does it Matter?
MTS HELPDESK:
Is the limit of quantitation always important when validating methods for impurities?
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?