Table 2.
List of FDA Interim Limits and Limits of Detection/Limits of Quantification (LODs/LOQs) for Impurities Assessed in Hand Sanitizers Marketed to Children.
| Chemical Name | CAS Number | Interim Limit Listed in FDA Guidance (ppm) a,b | LOD/LOQ (µg/g) c |
|---|---|---|---|
| 1-Propanol | 71-23-8 | NMT 1000 | 68.3 |
| Methanol | 67-56-1 | NMT 630 | 67.2 |
| Benzene | 71-43-2 | NMT 2 | 3.74 |
| Acetaldehyde | 75-07-0 | NMT 50 | 30.0 |
| Acetal | 105-57-7 | NMT 50 | 5.30 |
| Acetone | 67-64-1 | NMT 4400 | 67.2 |
| Ethyl Acetate | 141-78-6 | NMT 2200 | 76.6 |
| 2-Butanol | 78-92-2 | NMT 6200 | 68.7 |
| Isobutanol | 78-83-1 | NMT 21,700 | 68.3 |
| 1-Butanol | 71-36-3 | NMT 1000 | 68.9 |
| Isoamyl alcohol | 123-51-3 | NMT 4100 | 68.8 |
| Amyl alcohol | 71-41-0 | NMT 4100 | 68.9 |
a NMT = Not more than. b Methanol, benzene, and acetaldehyde have specific individual limits. The sum of all other impurities should not exceed 300 ppm. If the sum of all other impurities is >300 ppm, then each impurity in this category must meet the individual limit specified above. c Based on sample volume of 0.1 mL, density 0.850 g/mL.