Product Name |
Acetaminophen |
Other Name |
Paracetamol |
CAS No. |
103-90-2 |
Appearance |
White powder |
MF |
C8H9NO2 |
MW |
151.16 |
Specification |
98% |
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 |