Undenatured USP & FCC Ethanol · Ultra Pure
Pharmacopeial ethanol, with the TTB paperwork handled.
190 and 200 proof undenatured ethyl alcohol meeting Alcohol USP and Dehydrated Alcohol USP — for drug products, supplements, flavors and clean-label personal care, where a denaturant is not an option. Drums, totes, ISO and tanker, from a nine-facility bonded network.
Request a Quote & CoA → See the specificationsOr speak to the industrial desk: 203.662.9761
At a glance
What you can put on a purchase order today
190 & 200 proof
Undenatured. Alcohol USP and Dehydrated Alcohol USP. FCC on request.
5 gal → rail car
Pail, drum, 270-gal tote, ISO container, tanker truck, 28,500-gal rail car.
Bonded coverage
Multiple DSPs and bonded facilities for taxpaid and in-bond flexibility.
CoA with results
Actual values, not “conforms” — including the methanol result your incoming ID test needs.
Certifications carried on Ultra Pure alcohols
Certification scope varies by grade, feedstock and production site. Confirm the applicable certificates for your item on the quote.
Grades
Three grades. One conversation about which one you actually need.
The difference between these is not marketing. It is the monograph you are testing against on receipt, and it belongs on your specification before you order.
Alcohol USP
The workhorse pharmacopeial grade. Water-containing, and the correct choice wherever the formulation tolerates it.
- Monograph assay 94.9–96.0% v/v at 15.56 °C
- 92.3–93.8% w/w
- Specific gravity 0.812–0.816
- Undenatured — INCI name “Alcohol”
Dehydrated Alcohol USP
Anhydrous. Specified where water content interferes — extraction, non-aqueous formulation, moisture-sensitive APIs.
- Monograph assay not less than 99.5% v/v
- No upper limit — the monograph is a minimum
- Same impurity limits as Alcohol USP
- Aligns closely with Ph. Eur. 1318 anhydrous
FCC Ethyl Alcohol
For flavor, extract and dietary-supplement manufacturers whose specification calls FCC rather than USP.
- Methanol limit not more than 200 µL/L
- IR identification
- Dual USP + FCC certificate available on request
- Kosher and organic options
“190 proof = 94.9–96.0% v/v” is a category error. Under 27 CFR § 30.11, proof is twice the percent ethyl alcohol by volume at 60 °F, so 190.0 proof is exactly 95.0% v/v. The 94.9–96.0% figure is the monograph window, not the proof. Real assay typically runs a little above 190.0.
“200 proof = 100% ethanol” is not achievable in commerce. Dehydrated Alcohol USP requires not less than 99.5% v/v. “200 proof” is a trade designation for material meeting that minimum.
Who buys undenatured
Undenatured alcohol is a narrow product. Here is where it is the right one.
Most industrial ethanol demand is properly served by specially denatured alcohol, and we sell plenty of it. Undenatured wins in four situations, and we would rather route you correctly than sell you the wrong grade.
Oral and internal drug products
Anything ingested or absorbed systemically. A denaturant in the finished dosage form is not acceptable, so the excipient must be undenatured, monograph-compliant alcohol.
Dietary supplements & botanical extraction
Tinctures, liquid supplements and extracts where the solvent carries through to a consumed product. FCC or USP grade, kosher and organic options available.
Flavors and extracts
Where the alcohol is the carrier in a food product. This is also the classic profile of a 27 CFR Part 17 nonbeverage drawback claimant — see below.
Clean-label personal care
A brand that wants to declare plain “Alcohol” on the INCI list rather than “Alcohol Denat.” must buy undenatured. Denatured product carries the Denat. designation, full stop.
Tax & denaturing
The excise difference is about a dollar a proof gallon — not thirteen.
Almost every page on this subject tells you that specially denatured alcohol saves you the full $13.50 per proof gallon federal excise tax. That is wrong, and it leads buyers to specify a denatured grade they did not need. Here is the actual arithmetic.
| Specially Denatured Alcohol 27 CFR Parts 20 & 21 |
Undenatured, taxpaid + drawback 27 CFR Part 17 |
|
|---|---|---|
| Federal excise tax | Exempt | $13.50 / proof gallon paid up front |
| Recovered by drawback | Not applicable | $12.50 / proof gallon |
| Net federal excise cost | $0.00 / PG | ~$1.00 / PG |
| Contains a denaturant? | Yes | No |
| Fit for oral / internal drug product? | No | Yes |
| TTB burden on you | Industrial Alcohol User Permit, TTB F 5150.9; Part 20 recordkeeping | Part 17 registration; formula approval on TTB F 5154.1; claims on TTB F 5620.8 with F 5154.2; drawback bond |
| INCI declaration | Alcohol Denat. | Alcohol |
Drawback rate per 27 CFR § 17.141: drawback is paid at $1.00 less than the effective tax rate on each proof gallon used. Standard distilled spirits rate per TTB is $13.50 per proof gallon; CBMA reduced rates accrue to the producer or importer, not to the nonbeverage claimant.
So why does a cosmetic house still usually buy SDA?
Not the dollar. It is that SDA avoids Part 17 formula approval, the drawback bond, quarterly claims, and the working-capital float while you wait on the refund. If your product does not need denaturant-free alcohol, denatured is genuinely the easier path — and we will tell you so.
Tax-free alcohol under 27 CFR Part 22 is restricted to states and municipalities, tax-exempt educational and scientific institutions, hospitals, blood banks, sanitariums, non-profit clinics and qualifying laboratories. Section 22.102(b) prohibits its use in the manufacture of any product for sale, and prohibits sale of any product resulting from its use.
If you manufacture something you sell, your lawful routes are taxpaid alcohol with Part 17 drawback, or specially denatured alcohol under Parts 20 and 21. There is no third option, whatever a supplier’s landing page implies.
Which denatured formulas we also supply
Where denatured is the right answer, Ultra Pure carries SDA 2-B, 3-A, 3-C, 23-A, 30, 35-A, 38-B and 40-B at 190 and 200 proof, plus CDA 12-A, 18, 19, 20 and 35, and custom solvent blends. Note for clean-beauty formulators: SDA 39-C is denatured with diethyl phthalate, while SDA 40-B uses denatonium benzoate and tert-butyl alcohol — which is why brands avoiding phthalates typically specify 40-B.
Specifications
Monograph requirements, stated plainly.
The values below are the compendial requirements — the bar the material must clear. Lot-specific results come on the Certificate of Analysis with your shipment.
Assay — and why USP and Ph. Eur. are not interchangeable
| Alcohol USP | Ph. Eur. Ethanol (96 per cent), 1317 | |
|---|---|---|
| Reference temperature | 15.56 °C (60 °F) | 20 °C |
| Content, volume basis | 94.9 – 96.0% v/v | 95.1 – 96.9% V/V |
| Content, mass basis | 92.3 – 93.8% w/w | 92.6 – 95.2% m/m |
| Relative density | 0.812 – 0.816 | 0.805 – 0.812 |
| Anhydrous grade | Dehydrated Alcohol USP, NLT 99.5% v/v | Ethanol, anhydrous 1318, NLT 99.5% V/V |
The impurity limits are harmonised between USP and Ph. Eur. under PDG Stage 6. The assay windows and reference temperatures are not. If you file in both the US and EU, tell us at quote stage — the dual-compliance window is narrower than either monograph alone, and it should be written into your specification rather than discovered at goods-in.
Impurities — Alcohol USP and Dehydrated Alcohol USP
| Test | Limit | Why it is there |
|---|---|---|
| Limit of Methanol | NMT 200 µL/L | Also an Identification test — see the note below |
| Acetaldehyde and acetal | NMT 10 µL/L as acetaldehyde | Fermentation and oxidation by-products |
| Benzene | NMT 2 µL/L | Class 1 residual solvent under USP 〈467〉 |
| Sum of all other impurities | NMT 300 µL/L | Organic Impurities by GC — this is the modern control on higher alcohols |
| Nonvolatile residue | NMT 25 ppm (2.5 mg / 100 mL) | Loss on evaporation |
| Acidity | NMT 30 µL/L as acetic acid | |
| UV absorbance | NMT 0.40 at 240 nm | Broad screen for absorbing impurities |
A note on terminology: the current monograph contains no test named “fusel oil” or “amyl alcohol.” Higher alcohols are controlled through the Organic Impurities GC procedure and the 300 µL/L sum-of-others criterion. Suppliers still writing “tested for fusel oil” are quoting a superseded edition.
Following FDA findings of hand sanitizers labelled as ethanol that tested positive for methanol, USP added a Limit of Methanol test to the Identification section of both the Alcohol and Dehydrated Alcohol monographs, official 1 September 2020.
Because it is an identity specification, 21 CFR 211.84(d)(1) requires a drug manufacturer to test every lot received. No supplier certificate can substitute for that. What we can do is report the actual methanol result on the CoA rather than “conforms,” so that when a value trends you already have the history instead of opening an investigation blind.
Residual solvents
Ethanol is a Class 3 solvent under USP General Chapter 〈467〉, with low toxic potential and no health-based exposure limit needed; amounts of 50 mg per day or less, corresponding to 5,000 ppm under Option 1, are acceptable without justification. Note the distinction that trips people up: 〈467〉 governs ethanol as a residual solvent carried into your product. When ethanol is the excipient itself, its quality is governed by the Alcohol monograph and its Organic Impurities test. Both apply; they are not the same control.
Packaging & logistics
Five gallons to a rail car.
Undenatured alcohol moves under bond until it is taxpaid, which is why the shape of a supplier’s facility network matters more here than it does for a commodity chemical.
| Format | Volume | Construction | Typical net weight |
|---|---|---|---|
| Pail | 5 gallons (10 Pail Min.) | HDPE | 33.5 lbs |
| Drum | 55 gallons | HDPE or steel | 368.5 lbs |
| Tote | 270 gallons | HDPE | 1,809 lbs |
| ISO container | 6,500 gallons | Stainless steel | — |
| Tanker truck | 6,500 gallons | Stainless steel | — |
| Rail car | 28,500 gallons | Stainless steel | — |
Weights are nominal and vary with proof and container tare. Confirm on the quote.
If you intend to claim nonbeverage drawback, you must establish the actual quantity of taxpaid spirits used and the effective tax rate applied to them. That means proof and proof gallons need to appear on your paperwork, not just wine gallons. We state both as standard — it costs us nothing and saves you reconstructing it at claim time.
Documentation
Everything your incoming inspection and supplier file actually asks for.
Qualifying a new excipient supplier is work your QA team has to do about us. The less of it we make them invent, the faster we both get to a first order.
Certificate of Analysis
Actual results against each specification, not “conforms” — with lot number, date of manufacture, compendial designation, storage conditions and the manufacturing site identified.
Safety Data Sheet
Published as an indexed HTML page as well as PDF, so your team can find and cite a section without downloading anything.
Change notification
A written commitment not to change manufacturing site, process or raw-material source without prior notice, formalised in a quality agreement.
Supplier information pack
Site of manufacture, QMS status, supply-chain map and certificates — the inputs an EU Article 46(f) excipient risk assessment needs, in one file.
Common questions
What buyers ask us before the first order
Is 190 proof the same thing as Alcohol USP?
Not quite, and the distinction matters on a specification. 190.0 proof means exactly 95.0% ethanol by volume at 60 °F, per 27 CFR § 30.11. Alcohol USP is a window of 94.9–96.0% v/v. Material sold as 190 proof is the commercial grade that meets that monograph, and typical assay sits a little above the floor. Write the monograph on your spec, not the proof.
We file in both the US and the EU. Can one grade cover both?
For anhydrous, effectively yes — Dehydrated Alcohol USP and Ph. Eur. 1318 both require not less than 99.5%. For the 96% grade it is tighter than people expect: USP is 92.3–93.8% w/w referenced at 15.56 °C, Ph. Eur. 1317 is 92.6–95.2% m/m at 20 °C, so the dual-compliance window is the overlap. Tell us at quote stage and we will confirm against actual lot data before you write it into a specification.
Do we need a TTB permit to buy from you?
Not for undenatured taxpaid alcohol. You need an Industrial Alcohol User Permit, TTB Form 5150.9, to procure specially denatured alcohol, and for tax-free alcohol under Part 22 if you are an eligible institution. No permit is required to purchase completely denatured alcohol. If you plan to claim drawback you register under 27 CFR Part 17, which is a separate and lighter process.
Can we use tax-free alcohol to make our product?
No, if you sell that product. 27 CFR § 22.102(b) prohibits use of tax-free alcohol in the manufacture of any product for sale, and prohibits selling any product resulting from its use. Part 22 exists for hospitals, universities, non-profit clinics and qualifying laboratories. Commercial manufacturers use taxpaid alcohol with drawback, or SDA.
Will your CoA satisfy our incoming methanol testing?
It will inform it, but it cannot replace it. Since the 2020 revision, methanol is an identity specification in the Alcohol monograph, and 21 CFR 211.84(d)(1) requires identity testing on every lot received at your site. We report the actual methanol value rather than “conforms” so you have a trend line rather than a pass/fail.
What is the difference between “Alcohol” and “Alcohol Denat.” on our INCI list?
“Alcohol” is undenatured ethanol. “Alcohol Denat.” is the generic INCI name for denatured ethanol, covering the SD Alcohol grades — you may alternatively declare the specific formula, such as SD Alcohol 40-B. If your brand positioning requires the plain “Alcohol” declaration, you need undenatured material.
What are your minimums and lead times?
Quoted per item and per facility. Small formats through tanker are available; ask the industrial desk and we will give you a real answer rather than a range.
Do you hold excipient GMP certification?
Ask us directly and we will send the current scope of what we hold rather than a logo wall. We would rather have that conversation before you build a qualification file than after.
Tell us the monograph and the volume. We will do the rest.
Send us your specification, your target grade and your annual volume. We will come back with pricing, a representative Certificate of Analysis, the SDS, and a straight answer on whether undenatured is actually the right grade for what you are making.
Ultra Pure, LLC · 50 Old Kings Highway North, Darien, CT 06820
Industrial desk: 203.662.9761
Request a quote, CoA & sample
We reply within one business day. No newsletter signup, no drip sequence.