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CAS number： 103-90-2
Molecular formula： C8H9NO2
Molecular weight： 151.16
Packing: 25kg/bag or 25kg/drum
Valid time: 4 years
Type:Antibiotic and Antimicrobial Agents, Auxiliaries and Other Medicine
Specification:
Tests | Specification | Results |
Appearance | White or almost white, crystalline powder | White crystalline powder |
Identification | A:IR absorption | Positive |
B:HPLC | Positive | |
Heavy metals | Not more than 0.001% | Less than 0.001% |
Residue on ignition | Not more than 0.1% | 0.06% |
Loss on drying | Not more than 0.5% | 0.08% |
Organic impurities | Related compound B N-(4-Hydroxyphenyl) propanamide not more than 0.05% | 0.02% |
Related compound C N- (2-Hydroxyphenyl) acetamidenot more than 0.05% | 0.02% | |
Related compound D(N-Phenylacetamide) not more than 0.05% | 0.0001% | |
Related compound J N- (4-Chlorophenyl) acetamide（p-chloroacetanilide）not more than 0.001% | Not detected | |
Individual unspecified impurity not more than 0.05% | 0.02% | |
TotaI impurities not more than 0.1% | 0.05% | |
Free p―aminophenol | Not more than 0.005% | 0.0001% |
Assay(on the dried basis) | 98.0~102.0% | 99.8% |
Conclusion： | ||
Specification | Results | |||
Characters | Appearance | White or almost white, crystalline powder | Conforms | |
Solubility | Sparingly Soluble in water, freely soluble in alcohol, very slightly soluble in methylene chloride | Conforms | ||
Identification | Mp | 168℃-172℃ | Conforms | |
IR | Consider with the spectrum of paracetamol CRS | Conforms | ||
Loss on drying | ≤0.50% | 0.06% | ||
Sulphated ash | ≤0.1% | 0.03% | ||
Related Substances | Impurity J | (4-Chloroacetanilide) ≤10ppm | Below LOD | |
Impurity K | (4-Aminophenol) ≤50ppm | Below LOD | ||
Impurity F | (4-nitrophenol) ≤0.05% | Below LOD | ||
Any other impurity | ≤0.05% | ＜0.05% | ||
Total of other impurities | ≤0.1% | ＜0.1% | ||
Assay | 99.0%-101.0% | 99.4% | ||
Conclusion: Complies with EP9.0 | ||||
Function:
Paracetamol powder nutritional supplemen Mainly used for amino acid infusion,due to special wettability,also used in cold cream, osmetics. Serine constitute the human body of several kinds of essential amino acid of protein a, for the construction of protein has a very important role.
Application:
Paracetamol is approved for reducing fever in people of all ages.
Paracetamol is used for the relief of pains associated with many parts of the body. It has analgesic properties comparable to those of aspirin, while its anti-inflammatory effects are weaker. It is better tolerated than aspirin in patients in whom excessive gastric acid secretion or prolongation of bleeding time may be a concern.
CAS number： 103-90-2
Molecular formula： C8H9NO2
Molecular weight： 151.16
Packing: 25kg/bag or 25kg/drum
Valid time: 4 years
Type:Antibiotic and Antimicrobial Agents, Auxiliaries and Other Medicine
Specification:
Tests | Specification | Results |
Appearance | White or almost white, crystalline powder | White crystalline powder |
Identification | A:IR absorption | Positive |
B:HPLC | Positive | |
Heavy metals | Not more than 0.001% | Less than 0.001% |
Residue on ignition | Not more than 0.1% | 0.06% |
Loss on drying | Not more than 0.5% | 0.08% |
Organic impurities | Related compound B N-(4-Hydroxyphenyl) propanamide not more than 0.05% | 0.02% |
Related compound C N- (2-Hydroxyphenyl) acetamidenot more than 0.05% | 0.02% | |
Related compound D(N-Phenylacetamide) not more than 0.05% | 0.0001% | |
Related compound J N- (4-Chlorophenyl) acetamide（p-chloroacetanilide）not more than 0.001% | Not detected | |
Individual unspecified impurity not more than 0.05% | 0.02% | |
TotaI impurities not more than 0.1% | 0.05% | |
Free p―aminophenol | Not more than 0.005% | 0.0001% |
Assay(on the dried basis) | 98.0~102.0% | 99.8% |
Conclusion： | ||
Specification | Results | |||
Characters | Appearance | White or almost white, crystalline powder | Conforms | |
Solubility | Sparingly Soluble in water, freely soluble in alcohol, very slightly soluble in methylene chloride | Conforms | ||
Identification | Mp | 168℃-172℃ | Conforms | |
IR | Consider with the spectrum of paracetamol CRS | Conforms | ||
Loss on drying | ≤0.50% | 0.06% | ||
Sulphated ash | ≤0.1% | 0.03% | ||
Related Substances | Impurity J | (4-Chloroacetanilide) ≤10ppm | Below LOD | |
Impurity K | (4-Aminophenol) ≤50ppm | Below LOD | ||
Impurity F | (4-nitrophenol) ≤0.05% | Below LOD | ||
Any other impurity | ≤0.05% | ＜0.05% | ||
Total of other impurities | ≤0.1% | ＜0.1% | ||
Assay | 99.0%-101.0% | 99.4% | ||
Conclusion: Complies with EP9.0 | ||||
Function:
Paracetamol powder nutritional supplemen Mainly used for amino acid infusion,due to special wettability,also used in cold cream, osmetics. Serine constitute the human body of several kinds of essential amino acid of protein a, for the construction of protein has a very important role.
Application:
Paracetamol is approved for reducing fever in people of all ages.
Paracetamol is used for the relief of pains associated with many parts of the body. It has analgesic properties comparable to those of aspirin, while its anti-inflammatory effects are weaker. It is better tolerated than aspirin in patients in whom excessive gastric acid secretion or prolongation of bleeding time may be a concern.
