When I forcibly degrade my drug or drug product to create degradation products, how much degradation should I aim for?
Category: MTS Helpdesk
HPLC Autosampler Vials: Dos and Don’ts
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 some of the more common pitfalls.
Do I Have to Revalidate a Method if the HPLC Column is Changed?
I would like to have a ‘back-up’ column for my HPLC method so that I am not reliant on one supplier, but how can I choose one that will be suitable and do I need to validate the method fully on the replacement column?
What is Mass Balance in a Forced Degradation Study?
What is the ‘mass balance’ for an analytical method and is it critical that I investigate it as part of method development or method validation?
Why are ‘Bio’ Test Methods so Tricky to Validate?
When it comes to validation, analytical test methods used for medicinal products based on biological molecules can be a bit ‘tricky’ to deal with. Coming up with a suitable design for the validation protocol can be quite difficult. In particular, the choice of what parameters to investigate, and the design of the associated experiments. What are the main reasons for this?
Where do the Acceptance Criteria in Method Validation Come From?
One of the most difficult tasks when writing an analytical method validation protocol is to set suitable acceptance criteria, particularly for the characteristics of accuracy and precision. It sometimes seems that the values are just plucked out of the air! Available guidance documents, such as ICH Q2(R2), don’t mention any numbers.