All Services
The Challenge:
Elemental impurities pose toxicological risks to patients and can interfere with drug efficacy. Global pharmacopeias require stringent testing to ensure these elements remain below permitted daily exposure (PDE) limits.
Our Approach:
We provide highly sensitive elemental impurity profiling in accordance with ICH Q3D guidelines. Using state-of-the-art ICP-MS technology, we screen, quantify, and validate the presence of heavy metals and other residues across a wide range of complex matrices.
Why It Matters
Parts-per-billion (ppb) detection limits
Full ICH Q3D compliance
Rapid turnaround for critical release testing
Expert sample preparation for difficult matrices
Track Record
100+Projects Delivered
Applications
- Drug substances and excipients
- Finished pharmaceutical products
- Dietary supplements
- Extractables from packaging
Regulatory Standards
ICH Q3DUSP 232/233EP 5.20
Instrumentation
LC-MS/MS (Shimadzu LCMS-8045)High Sensitivity LC-MS/MS (Shimadzu LCMS-8060NX)High Sensitivity LC-MS/MS (Shimadzu LCMS-8060RX)ICP-MS (Agilent 7800, SPS 4 Autosampler)GC-MS/MS-FID (Agilent 8890, 7000D GC/TQ)UV Visible Spectrophotometer (Shimadzu)FTIR Spectrophotometer (Shimadzu)
Standards & Compliance
Every test we perform adheres to globally recognized regulatory frameworks.
ICH Q2ICH Q3DICH M7 (R1)USPEPBPJPIPFCCACSISO/IEC 17025ISO 10993-7US FDAEMACDSCO