Every solvent class, one headspace method.
Solvents don't fully evaporate; they hide in the powder, and the risk is set by the solvent's toxicity class, so USP <467> quantifies Class 1 down to single-digit ppm, holds Class 2 to its PDE, and confirms Class 3 stays under 0.5%.
Published. Per-test.
No quote calls.
Every assay a la carte, every panel bundled. Bulk discount at 5+ samples. Prices below reflect a single-compound submission.
The API/extract screen.
- USP <467> Class 1 + Class 2
- GC-headspace FID
- ICH Q3C PDE limits
- Public COA + accession #
All three classes.
- Class 1, 2, and 3 solvents
- FID quantitation + MS confirm
- ICH Q3C PDE reporting
- Public COA + accession #
For cannabinoid/botanical extracts.
- Extraction-solvent panel (ethanol/hexane/heptane/butane)
- USP <467> class limits
- MS confirmation on flags
- Public COA + accession #
Where residual solvents fail.
Residual-solvent exceedances trace to a few predictable places: aggressive Class 2 extraction, incomplete drying, light-hydrocarbon extraction in cannabinoids, and Class 1 contaminants riding in on a cheap Class 2 solvent.
USP <467>, ICH Q3C, ISO 17025 Aligned, 21 CFR Part 11.
The solvent's toxicity class sets the limit, and the compendia set the method. Here's what we map to on every residual-solvents COA.
The compendial chapter for organic volatile impurities — GC-headspace procedures and the Class 1/2/3 framework, with Class 1 and 2 quantified against defined limits and Class 3 under the 0.5% default.
The harmonized guideline that classifies solvents by toxicity and sets the permitted daily exposure (PDE) for each Class 2 solvent — the numbers behind the USP <467> limits.
The system-suitability and resolution requirements our GC methods follow so peaks are separated and quantitation is reproducible.
Heavy-metal impurities by ICP-MS, available as a paired add-on for a fuller impurity picture on an API or extract.
GC chromatograms and integration records retained per 21 CFR Part 11-style data-integrity principles, available to the client of record on request.
It quantifies the volatile organic solvents left in a finished powder or extract after synthesis, extraction, or recrystallization. USP <467> groups solvents into Class 1 (avoid), Class 2 (limit), and Class 3 (low toxicity, ≤ 0.5%) and sets limits by toxicity, measured by GC-headspace on a public COA.
