Chromatography Forum

Hi
I would like to know the procedure for RS method validation of one injectable product.
The method is directing to use undiluted sample (i.e. 1 mg/mL - as such sample) for RS method analysis. Injection volume is 100 µL.
I need to validate the method now. How can I spike the impurities to sample?
Can I go for concentrated formulation product and do 5 mL to 10 mL dilution in which I can spike the impurities?


Expecting someone to guide me in this...

That sounds like a good approach.

Dear
First you prepare concentrated stock solution of impurity which can you spike,and after spike as low as possible volume lke 0.1ml,0.2ml----0.5ml of impurity stock solution as per your requirement.I think less volume of impurity stock solution could not effect onquantification particularly in Related impurity method.

Thanks for your quotes.

But in this case, how can I proceed for Forced degradation (acid, base & Peroxide) experiment?...
Especially when the molecule is strong enough to resist degradation due to these pH changes and oxidation under mild conditions?...