FDA publishes hand sanitizer testing protocol to detect impurities

By Deanna Utroske

- Last updated on GMT

© Getty Images \ (Anchalee Phanmaha)
© Getty Images \ (Anchalee Phanmaha)

Related tags coronavirus Hand sanitizer Fda

This week, as part of its response to contaminated and unsafe hand sanitizers, the agency published a testing methodologies document. The protocols outlined in the new document can be used to determine the quality of finished sanitizer products.

Throughout the Coronavirus pandemic, the US Food and Drug Administration has been responding to new and emerging realities in personal care manufacturing and in the marketplace.

For instance in March, the FDA issued new guidance (for both manufacturers and pharmacists) on hand sanitizer production, as Cosmetics Design reported​. Current FDA guidance on hand sanitizer production can be found here on the FDA site​.

The agency has also created a running list of hand sanitizer products that are unsafe and which consumers should not use (that list can be found at the bottom of this FDA site page​).

And in April, an FDA update made it clear that hand sanitizer is not a medical treatment​, following misleading remarks made by the current administration.

FDA publishes testing protocol for hand sanitizer quality assessment

Now this week, the FDA has published a document outlining testing that can be used to determine if a given finished hand sanitizer product is contaminated by any “potentially harmful impurities,” ​according to the agency’s press release.

“This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities,” ​explains the FDA. “The testing method (with appropriate validation) can be used for hand sanitizers labeled with either alcohol (ethanol) or isopropyl alcohol (also called isopropanol or 2-propanol) as the active ingredient and can screen for potentially harmful impurities, as listed in FDA’s temporary guidances.”

FDA encourages GC-MS testing method for hand sanitizer safety test

The 11-page document published by the FDA on Monday, is all about how to effectively use the Direct Injection Gas Chromatography Mass Spectrometry Method of testing to determine if any unsafe impurities exist in hand sanitizer.

“The FDA has developed a laboratory analytical procedure to assess the quality of finished hand sanitizer products,” explains the document, which goes on to include a list of necessary reagents, sample prep guidelines, calculation details, and sample chromatograms. Find the new FDA hand sanitizer testing protocol document online here.

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