TAGS: Toiletries
FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products. The testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities.
Method Used to Test Alcohol-based Sanitizers
The Direct Injection Gas Chromatography Mass Spectrometry (GC-MS) 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 guidance.
Testing ethanol for methanol contamination is a quality standard set by the United States Pharmacopeia (USP) for alcohol used in pharmaceuticals (including hand sanitizers) and enforced by FDA pursuant to section 501(b) of the FD&C Act.
USP’s revision bulletin for alcohol and dehydrated alcohol monographs outlines this testing requirement, official as of 1 September 2020. FDA requested the revision of bulletin to protect health care providers and consumers from using dangerous hand sanitizer products.
Source: FDA