Elemental impurities in pharmaceutical formulations can interfere with drug efficacy or have a toxic effect on the patient. Regulators have issued guidelines — such as ICH Q3D, USP 232 and USP 233 Elemental Impurities — for monitoring a range of metal elemental impurities in pharmaceutical materials using inductively coupled plasma (ICP), optical emission spectroscopy (ICP-OES), or mass spectrometry (ICP-MS). In addition, alternative techniques such as atomic absorption spectroscopy (AAS) can be used if specific validation requirements described in the guidelines are met.
This compendium provides detailed methods for the analysis of trace elements in pharmaceutical products using AAS, ICP-OES and ICP-MS covered by the NEW USP chapters 232 and 233.
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