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Product Name: | Paracetamol | Appearance: | White To Pale Yellow Crystalline Powder |
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CAS: | 103-90-2 | Sample: | Yes |
High Light: | Local Anesthetic Agents,Injectable Local Anesthetics |
Tests | Standards | Results | |
Appearance | White or almost white ,crystalline powder. | White,crystalline powder. | |
Identification | A:IR absorption | Complies | Complies |
B:UV absorption | Complies | Complies | |
C:TLC | Complies | Complies | |
Melting point | 168~172C | 169.0~170.9C | |
Water | Not more than0.5% | 0.08% | |
Related substance | Impurity(chloroacetanilide)not more than 10 ppm | 2ppm | |
Impurity K(4-aminophenol)not more than 50 ppm | 15 ppm | ||
Impurity F(4-nitrophenol)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 |
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