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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

(a) Formula. To every 100 gallons of alcohol add:

  • Eight gallons of acetone, U.S.P.

Acetone: §21.49   Formula No. 23-H

(a) Formula. To every 100 gallons of alcohol add:

  • Eight gallons of acetone, U.S.P., and 1.5 gallons of methyl isobutyl ketone.

Eucalyptol, Thymol & Menthol: §21.64   Formula No. 37

(a) Formula. To every 100 gallons of alcohol add:

  • 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

(a) Formula. To every 100 gallons of alcohol add:

Ten pounds of any one, or a total of 10 pounds of two or more, of the oils and substances listed below:

  • Alpha terpineol
  • Anethole, N.F.
  • Anise oil, N.F.
  • Bay oil (myrcia oil), N.F. XI.
  • Benzaldehyde, N.F.
  • Bergamot oil, N.F. XI.
  • Bitter almond oil, N.F. X.
  • Camphor, U.S.P.
  • Cedar leaf oil, U.S.P. XIII.
  • Chlorothymol, N.F. XII.
  • Cinnamic aldehyde, N.F. IX.
  • Cinnamon oil, N.F.
  • Citronella oil, natural.
  • Clove oil, N.F.
  • Coal tar, U.S.P.
  • Cornmint oil.
  • Distilled lime oil.
  • Eucalyptol, N.F. XII.
  • Eucalyptus oil, N.F.
  • Eugenol, U.S.P.
  • Guaiacol, N.F. X.
  • L(-)-Carvone.
  • Lavender oil, N.F.
  • Lemon oil.
  • Menthol, U.S.P.
  • Methyl salicylate, N.F.
  • Mustard oil, volatile (allyl isothiocyanate), U.S.P. XII.
  • Peppermint oil, N.F.
  • Peppermint oil, terpeneless.
  • Phenol, U.S.P.
  • Phenyl salicylate (salol), N.F. XI.
  • Pine oil, N.F. XII.
  • Pine needle oil, dwarf, N.F.
  • Rosemary oil, N.F. XII.
  • Sassafras oil, N.F. XI.
  • Spearmint oil, N.F.
  • Spearmint oil, terpeneless.
  • Spike lavender oil, natural.
  • Storax, U.S.P.
  • Thyme oil, N.F. XII.
  • Thymol, N.F.
  • Tolu balsam, U.S.P.
  • Turpentine oil, N.F. XI.

Denatonium Benzoate & Tert-butyl Alcohol: §21.76   Formula No. 40-B

(a) Formula. To every 100 gallons of alcohol add:

  • 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

(a) Formula. To every 100 gallons of alcohol add:

  • 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.

 

 

Our expert blogger is Evan Boyst, Avomeen’s Senior Technical Director of Innovation and Product Development. He has facilitated the product launch from R&D to production of several products and has experience in developing personal care, industrial, and food and beverage formulations. 

Learn more about Evan’s expertise and experience.