Bitrex /Denatonium Benzoate-USP/NF to Produce SDA 40-B
To fight COVID19 crisis we are helping distilleries everywhere convert from production of liquor to the FDA/WHO hand sanitizer. Bitrex is the Bitterest Stuff on Earth and “denatures” to stop accidental or intentional ethanol ingestion. We are working with everyone, from local Rose City Distillers here in Portland, OR to the national trade organization Distilled Spirits Council of the United States. (https://www.distilledspirits.org/).
Ethanol Denaturing: **UPDATE AS OF 03/26/20** Under temporary FDA policies during the COVID-19 crisis the FDA/TTB “Specially Denatured Alcohol Formula 40-B” a.k.a. SDA-40B may now be used without the tert-butyl alcohol . You can just use the bittering agent, Bitrex, as listed in the US Code of Federal Regulations 27 CFR 21.76, it requires:
1/16th of an ounce of Bitrex/Denatonium Benzoate-USP/NF
0.125% t-Butyl Alcohol
100 Gallons 190 or 200 proof Ethanol
Under the FDA temporary policies, the ethanol used to produce hand sanitizer does not need to be 94.9% (FDA Policy 3/24), as long as the final hand sanitizer product meets final 80% ABV WHO standard.
Link to the "Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry" from the FDA Updated March 27, 2020 https://www.fda.gov/media/136118/download
Bitrex is EXTREMELY bitter. Only 4 Ounces treats 6400 gallons of ethanol. Please consult with us about handling this safe but unique chemical.
We are used to working in crisis management – our job is preventing poisonings- we help protect children and over 400 consumer brands. We respond quickly:
1) Bitrex is in-stock with same-day overnight shipping on orders before 1 pm PST.
2) We are immediately available to help with the unique and critical issues of handling the bitterest stuff on earth in beverage plants. Phone, Text, Email.
3) We are ready to consult as manufacturing chemists on both the SDA-40B and Hand Sanitizer.
We are proud to be a part of the US Chemical Industry to support the important work of the manufacturers of hand sanitizers, respirator fit testing solutions and cleaning products so critical during this unprecedented time.
Bitrex and Market Actives are active members in the American Cleaning Institute (ACI), ISSA - The Worldwide Cleaning Industry Association, and American Chemical Society (ACS).