Chromatography Forum

Dear experts,
We just got a regulatory inspection recently.

We got cited for using non-stability-indicating methods. They listed a product that we use UV/Vis spectrometer for the assays. The product is a complex matrix, and the actives are not small molecules.

Question: Could we make the non-HPLC tests to meet the SIM requirement?
Or should we create new HPLC tests, and abandon the old methods? It is nearly impossible (!) to develop any new test for this matrix. (Figuratively speaking, it's a dry bone with no meat).

Thanks for your input.
Alfred

Mass spec would work, but something tells me that's not what you had in mind!

Seriously, though, I would think that you could do it *if*:
1. you knew what the breakdown products were (which means that you would need LC and/or LC-MS data during stress testing) and
2. you could demonstrate that a non-separating method for one or more of those beakdown products would be interference free. To my mind, that would mean a dramatically different absorbance spectrum, or fluorescence, or ????

Those are some *very* big "ifs".

Per our other discussion, these requirements are part of the cost of admission to the pharma biz. It's then a management decision whether the investment to develop and validate the methods the FDA requires is financially viable or whether the product should be discontinued.