This useful compendium from Thermo Fisher 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.
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.
The specific applications covered within this compendium include:
Analysis by AAS
- Using graphite furnace atomic absorption to meet the requirements of elemental impurity analysis in pharmaceutical products for arsenic, cadmium and lead
- Using cold vapor generation atomic absorption to determine mercury impurities in pharmaceutical products
Analysis by ICP-OES
- Analysis of elemental impurities in drug products using the Thermo Scientific iCAP 7400 ICP-OES Duo
- Analysis of trace elements in Traditional Chinese Medicine (TCM)
- Analysis of trace elements in nutraceuticals in compliance with USP chapter <2232> Elemental Contaminants in Dietary Supplements
Analysis by ICP-MS
- Analysis of pharmaceutical products for their elemental impurities with the Thermo Scientific iCAP RQ ICP-MS
- The determination of elemental impurities in vitamin B12 supplements using the Thermo Scientific iCAP TQ ICP-MS