Dear All,

I have a compound called Ziprasidone, which is not dissolving any of the regularly used diluents like DMA,DMSO,DMF,Imidazolidinone etc... w.r.t 20mg/ml concentration.

Can anybody give suggestion on diluent selection for such cases.

I found the compound is soluble at a concentration of 5mg/ml in one of the above solvents. Can I go ahead for the method validation with 5mg/ml concentration?
Is it acceptable for regulatory authorities or any queries will come?

Can anybody advice please.

Thanks in advance.