In light of the COVID-19 pandemic, the FDA updated its guidance for its “nonbinding recommendations” for hand sanitizer manufacturing on August 7th, 2020. The document is titled “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).” The guidance didn’t change the overall recommended contaminant levels in ethanol. It added limits for products exceeding 300 ppm of “all other impurities.” The new guidance states that if ethanol meets Table 1 criteria, users can consider additional impurity limits. These additional limits are listed in Table 2 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.