NAD+observational1999

Validation of an enzymatic method for the determination of trace levels of ethanol.

Drug development and industrial pharmacy

confidence

Key findings

Analytical validation of enzymatic ethanol assay using ADH and NAD+; no clinical or biological endpoints reported.

Sample size: N/A
Population: N/A (analytical method validation study)
Dosing: N/A
Duration: N/A
Route: N/A
Blinding: not_reported
Controls: none
Drug class: coenzyme

Full abstract

The validation of an enzymatic method for the determination of trace levels of ethanol is described. The method, which involves the use of alcohol dehydrogenase (ADH) and nicotinamide adenine dinucleotide (NAD+), was validated according to USP 23 requirements. The validation parameters, including linearity and range, accuracy (recovery), precision, ruggedness, limit of detection (LOD), and limit of quantitation (LOQ), were established satisfactorily. The method is specific and selective for ethanol except in the presence of propyl, isopropyl, or butyl alcohol.

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