Pharmaceutical Intermediates Pain Killers Paracetamol/ Acetaminophen/ Panadol 103-90-2
Paracetamol is well absorbed in the gastrointestinal tract. Oral bioavailability is dose dependant: with larger doses, the hepatic first pass effect is reduced due to overwhelming of the liver enzymatic capacity; and therefore, bioavailability is increased. Rectal administration of paracetamol is also feasible. In this case, bioavailability is inconsistent and in overall reduced, due to incomplete dissolution of the suppository in the rectum. The absorption rate through this route of administration is elongated.
Paracetamol is distributed throughout the body fluids in a homogeneous way. The analgesic activity is attributable to the small fraction that penetrates into the brain. Paracetamol given at therapeutic doses binds to plasma proteins at less than 20%. In case of intoxication, this proportion may increase to up to 50%.
Paracetamol is essentially metabolized in the liver by conjugation with glucuronic acid (55%) and sulfuric acid (35%). Hepatotoxic metabolites are produced in small amounts by the cytochrome P450 (isoenzyme CYP2E1). In the therapeutic plasma concentration range, this metabolite is detoxified by conjugation with glutathione. In case of intoxication the amount of this toxic metabolite increases and outweighs the amount of available glutathion, which can lead to hepatic failure and renal tubular necrosis.
Paracetamol/ Acetaminophen/ Panadol Usage:
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,
Particularly suitable for carboxylic acid can not be used drugs patients. For the common cold, toothache embolism. Acetaminophen is intermediate in organic synthesis, photographic chemicals.Used as antipyretic, analgesic, anti rheumatic drugs.
| 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 |
|
2ppm |
|
15 ppm |
|
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% |
|
Not more than 0.001% |
Less than 0.001% |
| Readily carbonizable substances |
Conforms |
Conforms |
| Residual solvents |
|
0.08% |
| Assay(anhydrous basis) |
99.0~101.0% |
99.6% |
| Conclusion: Complies with USP34 / BP2011 |
| Test Items |
Specification |
Test Results |
| Appearance |
White or off-white powder |
white powder |
| Identification |
UV conform |
Conforms |
| Organic nitrogenous |
Conforms |
Conforms |
| Citrate |
Conforms |
Conforms |
| Water |
Not more than 1.0% |
0.35% |
| Heavy water |
Not more than 0.002% |
Conforms |
| Related impuries |
Related compound A:Not more than 2.0% |
0.84% |
| Individual:Not more than 0.5% |
0.36% |
| (Z)isomer |
Conforms |
Conforms |
| Organicvolatile impuritise |
Conforms |
Conforms |
| Assay |
Between98.0~102.0% |
99.5% |
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