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AN73987: Determination of Nitrite in Pharmaceuticals Be the first to rate this application


A method was developed for the determination of nitrite in pharmaceuticals by coupling IC with UV absorbance detection. The LOD of nitrite in a pharmaceutical sample is 0.918 ppm (μg/g API). The method is accurate and precise due to the high reproducibility of the Reagent-Free ion chromatography system. This method should be applicable to the determination of nitrite throughout the manufacturing process of a drug product to assess the likelihood of nitrosamine formation.
Market: BioPharma
Keywords: Diphenhydramine, Drug Substance, Losartan, Metformin, Ranitidine, RFIC, ion chromatography, Drug Product, NDMA, ADRS 600 Suppressor, Dionex ICS 6000 HPIC system, Dionex IonPac AS19-4μm column, n-nitrosamine, AN 73987
Matrix: Drug product, Drug substance
Author: Jingli Hu and Jeffrey Rohrer
Affiliation: Thermo Fisher Scientific, Sunnyvale, CA USA
Uploaded on 3/23/2021.

For Research Use Only. Not for use in diagnostic procedures.