AN73455: Determination of Nitrite Impurity in Dalteparin Sodium using Ion Chromatography
DescriptionIn this application note, the nitrite determination described in the USP monograph was evaluated with a Thermo Scientific Dionex IonPac AS15 column using an IC system. The method and conditions were exactly as described in the USP Dalteparin Sodium monograph. Key performance parameters were evaluated including the system suitability separation, linearity, limits of detection, accuracy, and robustness. One Dalteparin Sodium sample was analyzed. The percentage of nitrite result was compared with the USP acceptance criterium.
|Keywords:||Dionex IonPac AS15 Column, Drug Substance, Electrochemical detection, USP monograph, Dionex ICS-5000+ HPIC system, Dionex ICS-6000 HPIC system, AN 73445, glassy carbon working electrode|
|Author:||Jingli Hu and Jeffrey Rohrer|
|Affiliation:||Thermo Fisher Scientific|
For Research Use Only. Not for use in diagnostic procedures.