Lab glossary
Elemental impurities
Trace elements in drug products that give no therapeutic benefit, coming from catalysts, equipment, excipients, water or packaging. Controlled by risk assessment against PDEs under ICH Q3D and USP <232>.
- Also: heavy metals
- Also: metal impurities
- Also: ICH Q3D
Where you will meet this term
- InstrumentAtomic Absorption Spectrophotometer (AAS)
- InstrumentInductively Coupled Plasma Optical Emission Spectrometer (ICP-OES)
- InstrumentInductively Coupled Plasma Mass Spectrometer (ICP-MS)
- Test methodElemental Impurities by ICP-MS
- CalibrationICP-MS: Tuning & mass calibration
- CalibrationICP-MS: Detection limit check