|
Product Name |
Acetaminophen |
Other Name |
Acetaminophen |
|
CAS No. |
103-90-2 |
Appearance |
White powder |
|
MF |
C8H9NO2 |
MW |
151.16 |
|
Specification |
99%min |
Testing Method |
HPLC |
| Tests | Standards | Results |
| Appearance | White or almost white ,crystalline powder. | White,crystalline powder. |
| Identification | A:IR absorption | Complies |
| B:UV absorption | Complies | |
| C:TLC | Complies | |
| Melting point | 168~172°C | 169.0~170.9°C |
| Water | Not more than0.5% | 0.08% |
| Related substance | ImpurityJ(chloroacetanilide)not more than 10 ppm | 2ppm |
| Impurity K(4-aminophenolly)not more than 50 ppm | 15 ppm | |
| Impurity F(4-nitrophenolly)not more than 0.05% | Not detected | |
| any other impurity not more than 0.05% | 0.01% | |
| Total of other impurities not more than 0.1% | 0.02% | |
| Residue on ignition | Not more than 0.1% | 0.05% |
| Chloride | Not more than 0.014% | Less than 0.014% |
| Sulfate | Not more than 0.02% | Less than 0.02% |
| Sulfide | Conforms | Conforms |
| Heavy metals | Not more than 0.001% | Less than 0.001% |
| Free p-aminophenol | Not more than 0.005% | Less than 0.005% |
| Limit of P-chloroacetanilide | Not more than 0.001% | Less than 0.001% |
| Readily carbonizable substances | Conforms | Conforms |
| Residual solvents | Residual content of acetic acid is limited by the test of loss on dryingnot more than0.5% | 0.08% |
| Assay(anhydrous basis) | 99.0~101.0% | 99.6% |
| Conclusion: Complies with USP34/ BP2011 | ||