Application of LA-ICP-MS as a rapid tool for analysis of elemental impurities in active pharmaceutical ingredients

Abstract

The control of inorganic contaminants in active pharmaceutical ingredients has a significant role in the quality control of drug products. The concentration limits for metal residues in drug products have been defined by various regulatory guidelines. Laser ablation inductively coupled plasma mass spectrometry (LA-ICP-MS) is a powerful and fast analytical technique for multi-elemental analysis. A disadvantage in using LA-ICP-MS method is the lack of matrix reference materials for validation and calibration purposes. This article focuses on the handling strategy of laboratory-made matrix calibration standards for the quantification of elemental impurities in an active pharmaceutical ingredient by LA-ICP-MS.

Keywords: Arbidol; Elemental impurities; Laboratory reference materials; Laser ablation inductively coupled plasma mass spectrometry (LA-ICP-MS); Pharmaceutical ingredients.