USP Alcohol › Documentation
Documentation & supplier qualification
What arrives with the shipment, what arrives with the quote, and what your QA team needs from us to close a supplier file.
What a conforming excipient CoA carries
The IPEC Certificate of Analysis Guide sets out what a pharmaceutical excipient certificate should contain. We work to it because it removes an argument, not because it is decorative.
| Element | What we state |
|---|---|
| Manufacturing site | The original manufacturing site is identified by name and address, and identified separately from the distributing entity where those differ — so you can detect a site change. |
| Compendial designation | Alcohol USP, Dehydrated Alcohol USP, FCC, or the combination supplied. |
| Lot identification | Batch or lot number, date of manufacture, retest or expiration statement, storage conditions. |
| Specification table | Attribute, test method reference, acceptance criteria — alongside the actual result, not the word “conforms.” |
| Methanol | Reported as a value. See the note below on why this matters more than it used to. |
| Proof and proof gallons | Stated as standard, so a Part 17 drawback claim can be substantiated without reconstruction. |
| Approval | Authorised approver identity or compliant electronic signature with page numbering. |
After FDA identified hand sanitizers labelled as ethanol that tested positive for methanol, USP added a Limit of Methanol test to the Identification section of the Alcohol and Dehydrated Alcohol monographs, official 1 September 2020. Because methanol is now an identity specification, 21 CFR 211.84(d)(1) obliges a drug manufacturer to test every incoming lot for it. No certificate substitutes for that.
What a reported value does give you is a trend line. When a result moves within specification you can see it against history instead of opening an investigation with no baseline.
Safety data sheets, in HTML
Our SDS documents are published as indexed web pages as well as downloadable PDFs. That is a deliberate choice: a PDF is hard for your team to search, hard to cite a section from in a deviation report, and effectively invisible to the search and AI tools your engineers now use to answer a quick question. Section numbering follows GHS. Browse the SDS library →
Supplier qualification pack
Qualifying us is work your team has to do about us. Here is the package that shortens it, available on request at quote stage rather than after you have committed.
Site & supply chain
Site of manufacture, distribution route, and where material is held under bond — the supply-chain map an EU Article 46(f) excipient risk assessment asks for.
Quality system status
Current certifications with scope and expiry, sent as certificates rather than logos. Ask and you will get the real list.
Change notification commitment
Written undertaking not to change manufacturing site, process or raw material source without prior notice, formalised in a quality agreement.
Representative CoA & SDS
A real recent certificate for the grade you are evaluating, so your QA reviewer can assess the data package before a purchase order exists.
The recognised third-party scheme for excipient suppliers is EXCiPACT, built as GMP, GDP and Good Warehousing Practice annexes to ISO 9001. Certificates run three years with at least annual surveillance. Some competitors in this market hold it.
Rather than publish a logo wall, ask us for the current scope of what Ultra Pure holds and we will send the certificates. If there is a gap against what your qualification requires, you should know that before you build a file around us, not after.
What we will need from you
To quote accurately: the monograph or specification you test against, the compendia you must satisfy (USP, USP and Ph. Eur., FCC), the packaging format, annual volume, delivery location, and whether you intend to claim nonbeverage drawback. That last one changes the paperwork, not the product.