Analysis of ICH Q3D Guideline for Elemental Impurities in Drug Products Using ICPMS-2030
The ICH Q3D Guideline for Elemental Impurities sets permitted daily exposures (PDEs) for 24 elemental metal impurities of which toxicity is a concern, including the so-called big four (Pb [lead], Cd, [cadmium], Hg [mercury], and arsenic [As]), and residual catalyst metals that are added intentionally during active pharmaceutical ingredient synthesis. Here we describe an example of analysis of 24 elements included in the ICH Q3D guideline using inductively coupled plasma mass spectrometry.
- Content Type:
- Application
- Document Number:
- LAAN-A-CP-E032
- Product Type:
- Elemental Analysis, Inductively Coupled Plasma Emission Spectroscopy
- Keywords:
- Guideline for Elemental Impurities Q3D, Japanese Pharmacopoeia Sixteenth Edition, Drug product, Formulation, Pharmaceutical ingredient, Tablet, Collision cell, Mini-torch, Cd, Hg, As, Residual catalyst metals, Microwave sample pretreatment system, Pharmaceutical, Life Science, ICPMS-2030
- Language:
- English
- File Name:
- jpb416006.pdf
- File Size:
- 54kb
