About This Service
Our elemental impurity testing service provides ICH Q3D and USP <232>/<233> compliant analysis of 24 elemental impurities in pharmaceutical products. Using ICP-OES and ICP-MS with microwave digestion, we deliver accurate, sensitive, and regulatory-compliant results for APIs, drug products, excipients, and packaging materials.
Key Information
Accredited by
What's Included
Instruments Used
ICP-MS
Trace elemental analysis at ppb/ppt levels
ICP-OES
Multi-element analysis at ppm levels
Microwave Digestion System
Sample preparation for metals analysis
AAS (Flame/Graphite Furnace)
Single element confirmation analysis
Regulatory Standards
How We Work
Risk Assessment
Elemental impurity risk assessment performed per ICH Q3D decision tree.
Sample Preparation
Microwave-assisted acid digestion with certified reference standards.
ICP-MS/OES Analysis
Multi-element analysis with internal standards for accuracy and precision.
PDE Comparison & Report
Results compared against PDEs; compliance statement and full report issued.
Ready to Start Your Elemental Impurity Testing?
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