Reference standards for ICP-MS and ICP-OES
Elemental impurity methods under ICH Q3D are calibrated with single-element and multi-element standards, and the samples are digested in acid. The traceability of the standard is the anchor for the whole calculation, so the certificate has to state how the value was established.
What this method asks of a standard
| Requirement | Why it matters |
|---|---|
| Element standards with stated traceability | The certificate states the concentration and the basis on which it was established, which is what the PDE calculation in ICH Q3D relies on. |
| Matrix-matched calibrants | Where the digest matrix suppresses or enhances the signal, matrix-matched calibrants are used; the standard has to be compatible with that matrix. |
| Low blank contribution | At the levels Q3D requires, the blank contributed by the standard itself is part of the uncertainty budget. |
Standard types used with ICP-MS and ICP-OES
These are the catalogue groups most often quoted for ICP-MS and ICP-OES work. They are entry points into the catalogue, not a statement that any particular lot suits any particular method — that is established in your own validation, against the certificate for the lot.
- Impurity Reference Standards
- Fine Chemicals
- Chemical Reagents
- Browse by drug substance
- Certificate of analysis
Frequently asked
Why does traceability matter for an elemental impurity standard?
Can the same standard be used for ICP-MS and ICP-OES?
Related
Need a standard for a ICP-MS and ICP-OES method you are validating? Send the catalogue number or the structure and the quantity you need — a technical contact answers with availability and a quotation. Request a quote.