RS - Method validation for undiluted sample (injectables)

[mylsamyp]

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...

[Consumer Products Guy]

That sounds like a good approach.

[Rohit Hirpara]

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.

[mylsamyp]

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?...