In light of the ongoing COVID-19 pandemic, on August 7th, 2020 the FDA once again updated its guidance for its “nonbinding recommendations” for the manufacture of hand sanitizers. The guidance document is titled “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)” and can be viewed in .pdf format by clicking on the title above. This specific guidance did not change the overall recommended composition of contaminants in ethanol, but added some additional limits for products that fail to meet the 300 ppm limit on “all other impurities”. According to the new guidance, if ethanol meets the other criteria of Table 1 within the document (and shown below for convenience) then users and manufacturers can consider additional limits on other impurities that are now shown in Table 2 (also added below for convenience).
Table 1
| Impurity | Interim Limit under this policy |
| Methanol | NMT 630 ppm |
| Benzene | NMT 2 ppm |
| Acetaldehyde | NMT 50 ppm* |
| Acetal (1,1-diethoxyethane) | NMT 50 ppm |
| Sum of all other impurities | NMT 300 ppm |
Table 2
| Impurity | Interim Limit under this policy |
| Acetone | NMT 4400 ppm |
| n-propanol (1-propanol) | NMT 1000 ppm |
| Ethyl acetate | NMT 2200 ppm |
| Sec-butanol (2-butanol) | NMT 6200 ppm |
| Iso-butanol (2-methyl-1-propanol) | NMT 21700 ppm |
| n-butanol (1-butanol) | NMT 1000 ppm |
| iso-amyl alcohol (3-methyl-1-butanol) | NMT 4100 ppm |
| Amyl alcohol | NMT 4100 ppm |
Altiras offers hand sanitizers and also offers hand sanitizer recycling for products that no longer meet FDA requirements.