Validation of an Enzymatic Method for the Determination of Trace Levels of Ethanol

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 li...

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Veröffentlicht in:	Drug development and industrial pharmacy 1999-01, Vol.25 (8), p.929-935
Hauptverfasser:	Alvencar, R. V., Lam, S., Sidhom, M., Okarter, T. U.
Format:	Artikel
Sprache:	eng
Schlagworte:	Alcohol Dehydrogenase - chemistry Biological and medical sciences Ethanol - analysis General pharmacology Linear Models Medical sciences NAD - chemistry Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Reproducibility of Results Sensitivity and Specificity
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Zusammenfassung:	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.
ISSN:	0363-9045 1520-5762
DOI:	10.1081/DDC-100102253