Table 2. Results of FDA impurity analysis of ABHS samples from bulk refillable dispensers.
| Location | Analyte (Interim Threshold) a | Samples Non-Compliant with Temporary Guidance Document b | Average Content of Non-Compliant Samples (ppm) |
|---|---|---|---|
| Community settings (n = 51) | Methanol (630 ppm) | 5.88% (3/51) | 1,626 (± 610) |
| Benzene (2 ppm) | 0.00% (0/51) | N/A | |
| Acetal (50 ppm) | 35.29% (18/51) | 271 (± 227) | |
| Acetaldehyde (50 ppm) | 33.33% (17/51) | 202 (± 160) | |
| School district (n = 40) | Methanol (630 ppm) | 0.00% (0/40) | N/A |
| Benzene (2 ppm) | 0.00% (0/40) | N/A | |
| Acetal (50 ppm) | 2.50% (1/40) | 511 | |
| Acetaldehyde (50 ppm) | 0.00% (0/40) | N/A |
Summary of FDA chemical impurity testing for ABHS samples collected from bulk refillable dispenser in community settings (n = 51) and from a school district (n = 40).
a Interim thresholds established by FDA’s Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)—Guidance for Industry [10] are listed in parentheses. Samples in excess of these thresholds are considered non-compliant.
b Non-Compliant products are those where the analyte content was observed to be in excess of thresholds established by the Guidance Document [10]. Of the 117 total samples collected, 26 samples from community settings did not have sufficient material (after alcohol analysis) for FDA impurity analysis, yielding a total of 51 samples analyzed for these impurities. All 40 samples from the school district contained sufficient material for analysis. Standard deviation is provided in parentheses where averages are reported.