Class 1, 2 and 3 residual solvents in drug substances, excipients, dietary ingredients and their products.
| Tests | USP <467> Class 1 and 2 solvents; Class 1, 2 and 3 solvents |
|---|---|
| Method | Headspace gas chromatography with mass spectrometric detection |
| Results | Reported against the USP <467> limits or your specification, with pass/fail. |
| Price | Quoted per project |
USP <467> covers residual solvents left from the manufacture of drug substances, excipients and dietary ingredients and their products. The sample is sealed in a headspace vial and warmed; the vapor above it is separated by gas chromatography, and each solvent is identified and measured by mass spectrometry against reference standards.
These tests use headspace gas chromatography with mass spectrometric detection, as their names state, which is not the same as the chapter's own procedures. USP's residual solvents FAQ notes that the General Notices allow an appropriately validated alternative method. Whether this method suits your material, and how results are compared with the chapter's limits, is agreed for your project.
Tests for the Class 1 and Class 2 residual solvents of USP <467> by headspace gas chromatography with mass spectrometric detection. Class 1 solvents are those to be avoided and Class 2 solvents those to be limited. Tell us the article and the solvents your process could leave.
Adds the Class 3 solvents, which have low toxic potential, to the Class 1 and Class 2 solvents, by headspace gas chromatography with mass spectrometric detection. Tell us the article and the solvents your process could leave.
Send the material sealed in an airtight container with little headspace.
Tell us the article, the solvents used in its manufacture and the limits that apply. We confirm the sample amount at quote.
Questions about a sample or a method, call 360-967-7010 or email [email protected].
