Analysis of Impurities in Pharmaceuticals Using LCMS-9030 Quadrupole Time-of-Flight Liquid Chromatograph-Mass Spectrometer

User Benefits

- Highly accurate qualitative analysis for impurities in pharmaceuticals is possible by using this system. - The analysis software LabSolutions Insight Explore^TM can be used for composition estimation, database search for the structural formula, and fragment assignment analysis.

Introduction

It is extremely important to identify trace impurities in pharmaceuticals to guarantee their quality and safety. The structural formulas of impurities in pharmaceuticals are described in official documents such as the Japanese Pharmacopoeia (JP), the European Pharmacopoeia, and the United States Pharmacopeia. In general, the HPLC-UV method is widely used for analysis of impurities. In contrast, structural analysis using a mass spectrometer such as LC/MS/MS is attracting attention as a useful means for identifying detected impurities. This application news introduces an example of structural analysis of the impurities in montelukast sodium using the quadrupole time-of-flight (QTOF) mass spectrometer LCMS- 9030 and the software LabSolutions Insight Explore. Montelukast sodium is listed in the 17th edition of the JP and is used as a therapeutic drug for bronchial asthma and allergic rhinitis.

March 31, 2021 GMT