Chromatography Forum

Hi, all,

In my experience, lc/ms/ms is only used for bioanalytical analysis. Any of your have experience of application of lc/ms/ms in generic drug (solid dosage for example)company?

Generic drug company always contract its bioequivalance study out, do you think is there still any room for generic drug company to use LC/MS/MS? is it reallistic to use LC/MS/MS on a routine for the assay and test of generic drug? Did any of you even heard that LC/MS/MS is used as this?

It would be highly appreciated if your can provide some infromation about the application of lc/ms/ms in generic drug company!

LC/MS/MS is not only useful for bioequivalence or bioavailability studies. It is an excellent research tool for example for the identification of impurities, which may arise from new synthesis processes. Even if you buy the bulk drug and only work on new formulations, it is an excellent tool to identify new impurities and side products from the process or the interaction of the drug with the ingredients in the formulations.

UWE,

Very appreciate your reply! so are confirming that nobody use lc/ms for rountine assay and test of generic drug except the impurity identification, isn't it?