Spectrometric Results of Process Variations in Dacarbazine.

Intra-lot and inter-lot variability in dacarbazine was detected in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). One vial of six vials sampled from Fresenius Kabi Lot 6125612 appeared 7.8 SDs from the center of the rest of the vials on the DQS FTNIR screening assay. Spectra of 54 vials from six lots in the library clustered in two groups (p=0.02), suggesting they represent different material.