Paracetamol, also known as acetaminophen or APAP, is a medicine used to treat pain and fever. It is typically used for mild to moderate pain relief. Evidence for its use to relieve fever in children is mixed. It is often sold in combination with other medications, such as in many cold medications. In combination with opioid pain medication, paracetamol is also used for severe pain such as cancer pain and pain after surgery. It is typically used either by mouth or rectally but is also available intravenously. Effects last between two and four hours. Paracetamol is generally safe at recommended doses. Serious skin rashes may rarely occur, and too high a dose can result in liver failure. It appears to be safe during pregnancy and when breastfeeding. In those with liver disease, it may still be used, but in lower doses. Paracetamol is classified as a mild analgesic. It does not have significant anti-inflammatory activity and how it works is not entirely clear. Paracetamol was discovered in 1877. It is the most commonly used medication for pain and fever in both the United States and Europe. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. Paracetamol is available as a generic medication with trade names including Tylenol and Panadol among others. The wholesale price in the developing world is less than 0.01 USD per dose. In the United States it costs about 0.04 USD per dose.
Paracetamol is particularly useful when NSAIDs are contraindicated due to hypersensitivity or history of gastrointestinal ulceration or bleeding. It can also be used in combination with NSAIDs when these are ineffective in controlling dental pain alone.
Product name |
Acetaminophen (Paracetamol) |
Batch NO |
202210048A |
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Packing |
25kg/bag |
Quantity |
5675kg |
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MFG, Date |
2022.10.09 |
EXP. Date |
2026.10.08 |
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Analysis Date |
2022.10.13 |
Check NO. |
221013-02 |
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Standard |
EP9.0/BP2018 |
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Tests |
Specification |
Results |
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Characters |
Appearance |
A white or almost white, crystalline powder |
Conforms |
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Solubility |
Sparingly soluble in water, freely soluble in alcohol, very slightly soluble in methylene chloride |
Conforms |
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Identification |
Mp |
168℃~172℃ |
170.0-170.5℃ |
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IR |
Consistent with the spectrum of paracetamol CRS |
Conforms |
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Loss on drying |
≤0.5% |
0.06% |
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Sulphated ash |
≤0.1% |
0.04% |
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Related substances |
Impurity J |
(4-Chloroacetanilide)≤10 ppm |
Below LOD |
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Impurity K |
(4-Aminophenol)≤50ppm |
Below LOD |
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Impurity F |
(4-nitrophenol)≤0.05% |
Below LOD |
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Any other impurity |
≤0.05% |
<0.05% |
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Total of other impurities |
≤0.1% |
<0.1% |
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Assay |
99.0%-101.0% |
99.5% |
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Conclusion: It complies with the requirements of EP9.0/BP2018 |
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