USP grade ethanol, what is it?
There are a handful of ethanol grades each used for specific purposes, and ranked in order of quality. The most important for topical use is United States Pharmacopeia or USP grade. Then comes the Food Chemical Codex, or F.C.C grade to safeguard products for human consumption. Each of these dictates a set of purity standards that allows the use of ethanol in many different ways. Not all ethanol is created equal, and not all kinds of ethanol are suitable for every task1.
USP grade ethanol, in its simplest form, is ethanol that has passed purity tests as required by the USP. The United States Pharmacopeia – National Formulary (USP-NF) includes thousands of quality standards for medicines, active pharmaceutical ingredients, and inactive ingredients. The standards in USP-NF are used to help ensure the quality of medicines and their ingredients, and to protect the safety of patients2. This specific grade only includes 190 to 200 proof pure ethanol. Not all ethyl alcohol is USP grade, ethanol products have a proof associated with it, which is the water content within the ethanol product. Any level of proof can be manufactured based upon the amount of water added. However, the majority of all Ethanol products in pure or denatured are either 200 proof, 190 proof, 192 proof, or 140 proof.
The USP uses monographs to document quality standards. When it comes to ethanol these monographs articulate quality expectations for its identity, strength, purity, and performance4.
- Identity - Tests to identify that a particular substance is the product that it claims to be.
- Strength - Testing methods and acceptable ranges for the potency of a product, as reflected in the FDA's approvals.
- Purity - Information on impurities that may be present in a product and the amounts of these that are permitted, along with testing methods to identify and measure them.
- Performance - Laboratory tests to predict and demonstrate how a product will be released as it enters the human body.
USP certification does not signify the immediate ability to resale nor is it a license to market a product. It is a necessary step for ensuring public safety when it comes to the consumption and antiseptic use of ethanol. With that in mind, the Food Chemical Codex, or F.C.C also has stringent requirements that food-grade ethanol must go through. Before USP, the F.C.C was a publication of standards that have since been taken over by USP. However, the specifications are still used. It features over 1,200 monographs, including; food-grade chemicals, processing aids, food ingredients, flavoring agents, vitamins, and functional food ingredients5. The F.C.C serves two key roles in establishing integrity food-grade ingredients. First to serve as a widely known benchmark for regulatory agencies, food processors, and ingredient suppliers. Secondly, and most importantly, to limit any issues at the ingredients level.
There are a few more ethanol grades that can be explored. However, for human consumption or topical purposes like hand sanitizer, USP and/or F.C.C grade must be used.
FDA Guidance for USP Ethanol
Updated June 1, 2020
This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.
Temporary Policy for Manufacture of Alcohol for Incorporation Into AlcoholBased Hand Sanitizer Products During the Public Health Emergency (COVID-19)