S-02 · Contaminant & heavy metals
Every element. To the ppb.
ICP-MS elemental impurity profiling across the ICH Q3D catalogue. Trace metals, catalyst residues, and process contaminants — quantified against certified reference standards.
Standard TAT
72 hr
LOD
0.1 ppb
Sample req.
≥ 250 mg
Deliverable
Element panel PDF
Method reference
MA-S02-ICPMS-01
Instrument-calibrated● ValidatedSigned releaseRaw data retained
Method sheetHK · Kwun Tong
§ 01 — Assay scope
What is measured.
Every attribute is quoted, run, and reported against the same reference method. Add-ons run from the same submission.
A-01ICP-MS
Class 1 elements
As, Cd, Hg, Pb — the ICH Q3D 'always-tested' list, with PDE comparison.
A-02ICP-MS
Class 2A elements
Co, Ni, V — regulated when parenteral or inhalational route applies.
A-03ICP-MS
Class 2B & 3
Ag, Au, Ir, Os, Pd, Pt, Rh, Ru, Se, Tl, Li, Sb, Ba, Mo, Cu, Sn, Cr.
A-04ICP-MS · ICP-OES
Custom panels
Residual catalyst screens, packaging leachables, water-quality panels on request.
§ 02 — Method sheet
MA-S02-ICPMS-01
Abbreviated method sheet. Full validated method (linearity, robustness, system suitability) available under NDA.
Method code
MA-S02-ICPMS-01
Instrument
Agilent 7900 ICP-MS · ORS4 collision cell
Digestion
Closed-vessel microwave · HNO₃ / HCl / H₂O₂ as indicated
Internal standard
Sc, Ge, Rh, In, Tb, Bi (matrix-matched)
Calibration
5-point external, NIST-traceable standards
Reference
ICH Q3D(R2) · USP <232> <233>
Reporting limit
≤ 30% of PDE for oral route, tighter on request
§ 03 — Deliverable
A certificate you can hand to a regulator.
- Full element panel with PDE comparison and pass/fail flag
- Digestion log, calibration curve, and spike-recovery on file
- Signed by an authorised technical signatory (not the analyst)
- Raw ICP-MS data retained 5 years, exportable to CSV on request
- QR-verified serial on every CoA — batch-uniqueness enforced