USP Alcohol › Grades
Grades, proofs and compendial designations
What to write on the specification, and the differences that actually change a purchase order.
Proof is a legal definition, not a grade
Under 27 CFR § 30.11, proof is the ethyl alcohol content of a liquid at 60 °F stated as twice the percent of ethyl alcohol by volume. A proof gallon is a US gallon of proof spirits. So 190.0 proof is 95.0% v/v and 200.0 proof would be 100% — which is why 200 proof is a trade designation rather than a monograph term.
The grade is the monograph: Alcohol USP, Dehydrated Alcohol USP, or FCC Ethyl Alcohol. Write the monograph on your specification and the proof on your purchase order. Confusing the two is the most common source of a rejected lot at goods-in.
190 proof — Alcohol USP
| Attribute | Requirement |
|---|---|
| Ethanol content, by volume | Not less than 94.9% and not more than 96.0% v/v at 15.56 °C |
| Ethanol content, by weight | Not less than 92.3% and not more than 93.8% w/w |
| Specific gravity | 0.812 – 0.816 at 15.56 °C |
| Denatured? | No — INCI name “Alcohol” |
15.56 °C is exactly 60 °F. The monograph reference temperature is deliberately aligned with the TTB gauging temperature, which is why proof and monograph assay can be reconciled on the same certificate.
200 proof — Dehydrated Alcohol USP
| Attribute | Requirement |
|---|---|
| Ethanol content | Not less than 99.5% by volume at 15.56 °C |
| Upper limit | None — the monograph specifies a minimum only |
| Impurity limits | Identical to Alcohol USP |
| Ph. Eur. equivalent | Ethanol, anhydrous (1318), not less than 99.5% V/V at 20 °C |
FCC Ethyl Alcohol
The Food Chemicals Codex monograph, specified by flavor houses, extract manufacturers and dietary-supplement producers whose quality systems reference FCC rather than USP. FCC was revised in parallel with USP to add a methanol limit of not more than 200 µL/L and an infrared identification. A dual USP + FCC certificate is available on request and is usually the simplest route if you supply both regulated and food channels.
USP and Ph. Eur. dual compliance
Both monographs sit at PDG Stage 6 harmonisation, which is why the impurity limits match exactly. The assay windows do not.
| Alcohol USP | Ph. Eur. 1317 | |
|---|---|---|
| Reference temperature | 15.56 °C | 20 °C |
| Content, volume | 94.9 – 96.0% v/v | 95.1 – 96.9% V/V |
| Content, mass | 92.3 – 93.8% w/w | 92.6 – 95.2% m/m |
| Relative density | 0.812 – 0.816 | 0.805 – 0.812 |
Percent m/m is temperature-invariant; percent v/v is not. Since USP references 15.56 °C and Ph. Eur. references 20 °C, the only fair comparison of the two windows is on mass. The dual-compliance window is the overlap of the two mass ranges — narrower than either monograph alone.
If you file in both territories, tell us before you write the specification. We will confirm the achievable window against actual lot data rather than have you discover it at incoming inspection.
When you need denatured instead
Ultra Pure supplies SDA 2-B, 3-A, 3-C, 23-A, 30, 35-A, 38-B and 40-B at 190 and 200 proof, CDA 12-A, 18, 19, 20 and 35, plus custom solvent blends and an organic certified SDA 38-B. See Tax & Compliance for which route applies to your product, and note that procuring SDA requires an Industrial Alcohol User Permit on TTB Form 5150.9 while CDA does not.