Reference standards for GC-MS and GC-MS/MS
GC-based methods are used where the analyte is volatile or can be made volatile: residual solvents, volatile nitrosamines, some genotoxic impurities. The standard has to survive the inlet — which is why the certificate matters as much as the catalogue number.
What this method asks of a standard
| Requirement | Why it matters |
|---|---|
| Volatile nitrosamines | NDMA, NDEA and related nitrosamines are typically determined by GC-MS/MS or LC-MS/MS. Both need the individual nitrosamine as a calibration standard. |
| Residual solvents | Class 1, 2 and 3 solvent standards are usually certified reference materials; the certificate states the identity and purity that the limit calculation depends on. |
| Thermal stability information | A standard that decomposes in the inlet gives a low response that looks like a recovery problem. Storage and shipping conditions are stated on the certificate so the material arrives as characterised. |
Standard types used with GC-MS and GC-MS/MS
These are the catalogue groups most often quoted for GC-MS and GC-MS/MS 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.
- Nitrosamine Standards
- Impurity Reference Standards
- Fine Chemicals
- Browse by drug substance
- Certificate of analysis
Frequently asked
Why do nitrosamine methods need a dedicated standard?
Is a purity figure enough for a residual solvent limit test?
Related
Need a standard for a GC-MS and GC-MS/MS 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.