Source: https://www.avomeen.com/the-use-of-alternative-denaturants-in-disinfectants-sanitizing-products/
Timestamp: 2020-06-02 07:53:50
Document Index: 117480195

Matched Legal Cases: ['art 21', '§21', '§21', '§21', '§21', '§21', '§21']

The Use of Alternative Denaturants in Disinfectants & Sanitizing Products
As we come together to fight COVID-19, many are finding that needed raw materials are in short supply. Numerous manufacturers of disinfectants and hand sanitizing products are facing denaturant shortages, and are looking for alternative denaturants given a limited supply of isopropyl alcohol. The Code of Federal Regulations (CFR) Title 27, Chapter 1, Subchapter A, Part 21 details a list of alternate denaturant formulas approved for both disinfectants and hand lotions. These alternative denaturants are suitable for use in hand sanitizer formulations. Additionally, if the following approved formulas were to be used in hand sanitizer formulations, there would be no need for Repeat Insult Patch Testing (RIPT).
Alternatives to Isopropyl Alcohol
Acetone: §21.47 Formula No. 23-A
Eight gallons of acetone, U.S.P.
Acetone: §21.49 Formula No. 23-H
Eight gallons of acetone, U.S.P., and 1.5 gallons of methyl isobutyl ketone.
Eucalyptol, Thymol & Menthol: §21.64 Formula No. 37
Forty-five fluid ounces of eucalyptol, N.F. XII, 30 avoirdupois ounces of thymol, N.F., and 20 avoirdupois ounces of menthol, U.S.P.
Multi-Component Formula: §21.65 Formula No. 38-B
Ten pounds of any one, or a total of 10 pounds of two or more, of the oils and substances listed below:
Cornmint oil.
Distilled lime oil.
L(-)-Carvone.
Mustard oil, volatile (allyl isothiocyanate), U.S.P. XII.
Peppermint oil, terpeneless.
Denatonium Benzoate & Tert-butyl Alcohol: §21.76 Formula No. 40-B
One-sixteenth avoirdupois ounce of denatonium benzoate, N.F., and 1⁄8 gallon of tert-butyl alcohol.
Tert-butyl Alcohol: §21.77 Formula No. 40-C
Three gallons of tert-butyl alcohol.
How Avomeen Can Help with Sanitizer & Disinfectant Formulation Modifications
Avomeen’s staff of experienced formulators stand ready to join you in the fight against COVID-19. If you’re facing challenges identifying alternative denaturants and are looking for assistance in modifying sanitizer or disinfectant formulations, let’s talk.