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 |
168~172C |
169.0~170.9C |
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 |
Application
1.This product is acetanilide antipyretic analgesics. By inhibiting ring oxidase and selectivity in the hypothalamus of the temperature regulating center, the synthesis of prostaglandins in peripheral vascular expansion, sweating and antipyretic effect, strength of its antipyretic effect similar to aspirin.
2.Antipyretic analgesics, international non proprietary drug called Paracetamol. It is the most commonly used non anti-inflammatory antipyretic analgesic, antipyretic effect similar to aspirin, the analgesic effect is weak, no anti rheumatic effects of anti inflammation, is the best varieties of acetanilide drugs.
3.Particularly suitable for carboxylic acid can not be used drugs patients. For the common cold, toothache embolism. Acetaminophen is intermediate in organic synthesis, hydrogen peroxide stabilizer, photographic chemicals.Used as antipyretic, analgesic, anti rheumatic drugs.
Medical uses of Paracetamol
Fever
Paracetamol is used for reducing fever in people of all ages.The World Health Organization (WHO) recommends that paracetamol be used to treat fever in children only if their temperature is greater than 38.5 °C (101.3 °F).The efficacy of paracetamol by itself in children with fevers has been questioned and a meta-analysis showed that it is less effective than ibuprofen.
Pain
Paracetamol is used for the relief of mild to moderate pain. The use of the intravenous form for pain of sudden onset in people in the emergency department is supported by limited evidence.
Osteoarthritis
The American College of Rheumatology recommends paracetamol as one of several treatment options for people with arthritis pain of the hip, hand, or knee that does not improve with exercise and weight loss. A 2015 review, however, found it provided only a small benefit in osteoarthritis.
Paracetamol has relatively little anti-inflammatory activity, unlike other common analgesics such as the NSAIDs aspirin and ibuprofen, but ibuprofen and paracetamol have similar effects in the treatment of headache. Paracetamol can relieve pain in mild arthritis, but has no effect on the underlying inflammation, redness, and swelling of the joint. It has analgesic properties comparable to those of aspirin, while its anti-inflammatory effects are weaker. It is better tolerated than aspirin due to concerns with bleeding with aspirin.
Low back pain
Based on a systematic review, paracetamol is recommended by the American College of Physicians and the American Pain Society as a first-line treatment for low back pain. However other systematic reviews concluded that evidence for its efficacy is lacking.
Headaches
A joint statement of the German, Austrian, and Swiss headache societies and the German Society of Neurology recommends the use of paracetamol in combination as one of several first line therapies for treatment of tension or migraine headache.In the treatment of acute migraine, it is superior to placebo, with 39% of people experiencing pain relief at 1 hour compared to 20% in the control group.
Postoperative pain
Paracetamol, when combined with NSAIDs, may be more effective for treating postoperative pain than either paracetamol alone or NSAIDs alone.
Other
The efficacy of paracetamol when used in combination with weak opioids ( improved for approximately 50% of people but with increases in the number experiencing side effects. Combination drugs of paracetamol and strong opioids improve analgesic effect.
The combination of paracetamol is superior to paracetamol alone for the treatment of common pain conditions including dental pain, postpartum pain, and headache.
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