Validation of Analysis Method Using ICPMS-2030 Based on USP <233> ELEMENTAL IMPURITIES - PROCEDURES

In the United States Pharmacopeia General Chapters USP <233>, inductively coupled plasma-mass spectrometry (ICP-MS) is recommended as the analysis procedures. In this paper, validation of the analytical method using a Shimadzu ICPMS-2030 was carried out in accordance with USP <233>. The tested materials were constituent ingredients used in oral formulations. The accuracy, precision, limit of quantitation and specificity of 24 target elements are presented, assuming measurements below the Control Threshold, 30% of the PDEs.

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Elemental Analysis, Inductively Coupled Plasma Emission Spectroscopy
ICP-MS, ICH Q3D, drug products, PDE, validation, USP <233>, Elemental Impurities, accuracy, precision, limit of quantitation, specificity, oral formulations, Pharmaceutical, Life Science, ICPMS-2030
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