The validation of an enzymatic method for the determination of trace levels
of ethanol is described. The method, which involves the use of alcohol deh
ydrogenase (ADH) and nicotinamide adenine dinucleotide (NAD(+)), was valida
ted according to USP 23 requirements. The validation parameters, including
linearity and range, accuracy (recovery), precision, ruggedness, limit of d
etection (LOD), and limit of quantitation (LOQ), were established satisfact
orily. The method is specific and selective for ethanol except in the prese
nce of propyl, isopropyl, or butyl alcohol.