Residual Solvents
USP <467>
Method Description
Residual solvents are volatile organic chemicals left behind from extraction, purification and formulation — hexanes, ethanol, acetone, chlorinated solvents and others. USP <467> classifies them by toxicity and sets concentration limits, and finished products and ingredients are expected to show them below those limits. This panel quantifies 31 solvents, including ethylene oxide, in a single headspace GC-MS run and reports each in µg/g (ppm) for comparison with USP <467> Class 1, 2 and 3 limits. Used by extract manufacturers, ingredient suppliers and finished-product brands for release and supplier qualification.
Analyte List
| Analyte Name | LOD | LOQ | LCL |
|---|---|---|---|
| 1,1-Dichloroethene | 5.000 ug/g | 10.000 ug/g | N/A |
| 1,2-Dichloroethane | 0.500 ug/g | 1.000 ug/g | 0.250 ug/g |
| 2,2-Dimethylbutane | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| 2,3-Dimethylbutane | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| 2-Methylbutane | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| 2-Methylpentane | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| 3-Methylpentane | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Acetone | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Acetonitrile | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Benzene | 0.180 ug/g | 0.500 ug/g | 0.250 ug/g |
| Butane | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Chloroform | 0.780 ug/g | 1.000 ug/g | 0.250 ug/g |
| Ethanol | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Ethyl Acetate | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Ethyl Ether | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Ethylene Oxide | 2.000 ug/g | 4.000 ug/g | 1.000 ug/g |
| Heptane | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Hexane | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Isobutane | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Isopropyl Alcohol | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Methanol | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Methylene Chloride | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Neopentane | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Pentane | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Propane | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Toluene | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Total Xylenes | 5.000 ug/g | 10.000 ug/g | 2.500 ug/g |
| Trichloroethylene | 0.500 ug/g | 1.000 ug/g | 0.250 ug/g |
| Total Butanes | N/A | N/A | N/A |
| Total Hexanes | N/A | N/A | N/A |
| Total Pentanes | N/A | N/A | N/A |
Technical Data Sheet
Information required by submitted
If known, list the solvents used in processing so the report can highlight them.
Additional information
Modified USP <467> procedure: static headspace sampling with GC-MS detection in place of the compendial GC-FID configuration; solvent classes 1, 2 and 3 plus ethylene oxide. Total Hexanes, Total Pentanes, Total Xylenes and Total Butanes are calculated sums of the isomers.
Residual Solvents
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