Related substance test method when applying DMF to FDA

[vanjas]

Thanks for everyone reading this ..
My question is like this..
The related substance test method for Ursodiol in USP is TLC Method.
Even if there is a compendial method for API, is it additionally necessary to quantitate all related impurities in the API by HPLC or other quantitative method including validation when we apply Drug Master File to FDA ??

Anyone who has an experience on this matter will be helpful to me..

Thanks for reading...

[Sunjay]

I think it will be required, as your mfg process may be different and your impurities may differ also.

So it would be better to have a quantitative method at least for the stability.

In my previous compnay, we have separated method for the impurities for Cefadroxl, as in USP it is by TLC.

Hope this will help you. ]

Do any one have different view on this?

Thanks