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