USP 35 Acetaminophen manufacturer API
CAS No.:103-90-2 EINECS No.: 203-157-5
NO.:TW-08-055
Product name | Acetaminophen (Paracetamol) |
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Batch NO. | 1508023006 | Packing | 25kg / fibre drum |
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MFG. Date | 2015.8.23 | Quantity | 1006Kg |
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EXP. Date | 2019.8.21 | Analysis Date | 2015.8.26 |
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Standard | USP35 |
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Contents | Specification | Results |
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Characters | White crystalline powder | Conforms |
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Identification | IR,UV,TLC Complies with the test for identification of Paracetamol | Conforms |
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Melting point | 168-172ºC | 169.3-170.0ºC |
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Loss on drying | ≤0.5% | 0.09% |
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Residue on ignition | ≤0.1% | 0.05% |
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Chloride | ≤0.014% | ≤0.014% |
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Sulfate | ≤0.02% | ≤0.02% |
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Sulfide | Conforms | Conforms |
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Heavymetals | ≤0.001% | ≤0.001% |
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Readily arbonizable substances | Conforms | Conforms |
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Free p-aminophenol | ≤0.005% | ≤0.005% |
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Limit of p-chloroacetanilide | ≤0.001% | ≤0.001% |
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Organic volatile impurities | Conforms | Conforms |
Assay | 98.0%-101.0% | 99.72% |
Conclusion: It complies with the requirements of the USP35 |
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