Identification and analysis of persistent contaminants associated with gemcadiol.

Application of several analytical probes indicated that certain batches of the investigational new drug gemcadiol (2,2,9,9-tetramethyl-1,10-decanediol) were contaminated with impurities whose nature and source were unknown. Subsequent study showed that these impurities consisted of polymeric material formed by self-condensation of the dialdehyde precursor. Gel permeation chromatographic techniques were found to be useful in the analysis of polymers present in both the aldehyde precursor and the finished drug.