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Paracetamol, also known as acetaminophen or APAP, is a medication used to treat pain and fever. It is typically used for mild to moderate pain. There is poor evidence for fever relief in children. It is often sold in combination with other ingredients such as in many cold medications. In combination with opioid pain medication, paracetamol is used for more severe pain such as cancer pain and after surgery.
· Formula: C8H9NO2
· Molecular weight: 151.170
· Assay: 99.0%min.
· Appearance: White crystalline powder
· Melting point: 168-172
· Standard: USP32 or higher grade
Specification:
|
Item |
Standard (USP30/BP2008) |
Test Result |
|
Appearance |
white crystalling powder |
Conform |
|
Identification |
Positive |
Conform |
|
Melting range |
168172 |
169.2170.1 |
|
Water |
≤ 0.5% |
0.10% |
|
Related substance |
ImpurityJ(chloroacetanilide)≤10ppm |
4ppm |
|
Impurity K(4-aminophenol)≤50ppm |
6ppm |
|
|
Impurity F(4-nitrophenol)≤0.05% |
0.02% |
|
|
Any other impurity ≤0.05% |
0.03% |
|
|
Total of other impurity ≤0.1% |
0.05% |
|
|
Residue on ignition |
≤ 0.1% |
0.08% |
|
Chloride |
≤ 0.014% |
0.014% |
|
Sulfate |
≤ 0.02% |
0.02% |
|
Sulfide |
Conforms |
Conforms |
|
Heavy metals |
≤ 0.001% |
0.001% |
|
Free p-aminophenol |
≤ 0.005% |
0.005% |
|
Limit of p-chloroacetanilide |
≤ 0.001% |
0.001% |
|
Assay |
99.0%101.0% |
99.40% |
|
Readily carbonizable substances |
Conforms |
Conforms |
|
Organic volatile impurities |
Conforms |
Conforms |
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
