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25 Kilogram |
Negotiable |
103-90-2 Paracetamol 4-Acetamidophenol
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Paracetamol powder BP/USP 103-90-2 pharmaceutical raw material/Paracetamol
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 |
168~172°C |
169.0~170.9°C |
|
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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