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1.Product Name: Paracetamol
2.CAS NO: 103-90-2
3.Application: Used as analgesic, antipyretic and antirheumatic drugs
4.Sample: With Free
5.Specification:
Tests |
Standards |
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Appearance |
White or almost white ,crystalline powder. |
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Identification |
A:IR absorption |
Complies |
B:UV absorption |
Complies |
|
C:TLC |
Complies |
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Melting point |
168~172°C |
|
Water |
Not more than0.5% |
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Related substance |
ImpurityJ(chloroacetanilide)not more than 10 ppm |
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Impurity K(4-aminophenol)not more than 50 ppm |
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Impurity F(4-nitrophenol)not more than 0.05% |
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any other impurity not more than 0.05% |
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Total of other impurities not more than 0.1% |
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Residue on ignition |
Not more than 0.1% |
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Chloride |
Not more than 0.014% |
|
Sulfate |
Not more than 0.02% |
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Sulfide |
Conforms |
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Heavy metals |
Not more than 0.001% |
|
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Free p-aminophenol |
Not more than 0.005% |
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Limit of P-chloroacetanilide |
Not more than 0.001% |
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Readily carbonizable substances |
Conforms |
|
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Residual solvents |
Residual content of acetic acid is limited by the test of loss on dryingnot more than0.5% |
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Assay(anhydrous basis) |
99.0~101.0% |
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Conclusion: Complies with USP34/ BP2011 |
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