What is Denatured Ethanol?
Denatured ethanol or denatured alcohol or ethyl alcohol is a clear, colorless, flammable liquid. Ethanol is available in many concentrations, grades, and purities. It has applications in food, medicine, and manufacturing. Due to its unique solvent properties, ethanol is used by oil extraction specialists in the hemp industry, as a denaturant for tissue cultures, and universities to conduct research. It has a cleansing ability on bacteria and viruses. Denatured ethanol which is made unfit for human consumption directly by adding one or more denaruants to it.
For many industrial applications, denaturants, such as isopropanol, methanol and over 100 other compounds, do not interfere with analytical or production protocols. The use of denaturants is used to make the ethyl alcohol (ethanol) undrinkable and exempt from the Bureau of Alcohol, Tobacco, and Firearms regulation. There are a number of ethanol products with specifications tailored to meet your analytical or other technical needs.
Denatured Ethanol Formulation
Denatured Ethanol or Specialty Grade Alcohol grade SDA 40-B, 200 proof or 190 proof is used for hand sanitizer production and extraction. Formulation for SDA 40-B: To every 100 us gallons of 190 Proof pure alcohol add: 0.0625 av. Oz of denatonium benzoate, N.F., and 0.125 us gallon of tert-butyl alcohol.
FDA Denatured Guideline for hand sanitizer
The FDA released the following statements on March 27th, 2020 Production of Hand Sanitizer to Address the COVID-19 Pandemic
Tax-free ethanol may be used to produce hand sanitizer if it is denatured according to TTB regulations and Food and Drug Administration (FDA) guidance.
Alcohol, whether or not denatured, may be delivered tax-free to state and local governments for non-beverage purposes. The same is true for hospitals, blood banks, sanitariums, certain pathological laboratories, non-profit clinics, and qualifying educational institutions, if not for resale or use in the manufacture of any product for sale.
(TTB) has found it desirable to waive provisions of internal revenue law with regard to distilled spirits, and therefore is providing certain exemptions and authorizations to distilled spirits permittees who wish to produce ethanol-based hand sanitizers to address the demand for such products during this emergency. Any existing DSP therefore can immediately commence production of hand sanitizer or distilled spirits (ethanol) for use in hand sanitizer without having to first obtain authorization.
TTB is authorizing the manufacture of hand sanitizer products by DSPs using a formulation in the FDA guidance cited above without first obtaining formula approval from TTB.
Industrial alcohol user permittees may also use denatured ethanol to manufacture hand sanitizer using a formulation in the FDA guidance without first obtaining formula approval from TTB. During the period covered by this guidance, TTB is also exempting industrial alcohol user permittees from the requirement to request approval from TTB to increase the quantities of denatured ethanol that they may procure.