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Acetaminophe
Product name: Acetaminophen
Synonyms: 4-Acetamidophenol
Cas No.: 103-90-2
Molecular Formula: C8H9NO2
Molecular Weight: 151.16
Density: 1.293
Melting Point: 168-172 °C
White crystalline powder
Tests
Specification
Test reference
ResultsAppearance:White, odourless, crystalline or crystalline powder.
USP monograph for Acetaminophen
Conforms
Solubility: Freeli soluble in alcohol; soluble in boiling water and in 1N sodium hydroxide
Conforms
Identification:
A & B should be positive
USP monograph for Acetaminophen
Conforms
Loss on Drying:
≤0.5%
USP <731>
0.11%
Residue on Ignition:
≤0.1%
USP <281>
0.02%
Limit of free p-Aminophenol
≤0.005%
USP monograph for Acetaminophen
HPLC method
ND
Organic Imurity
Relaed compound B: ≤0.05%
(N-(4-Hydroxyphenyl) propenamide )
USP monograph for Acetaminophen
HPLC method
0.010%
Relaed compound C: ≤0.05%
(N-(2-Hydroxyphenyl) Acetamide )
ND
Relaed compound D: ≤0.05%
(N-Phenylacetamide )
0.005%
Relaed compound J: ≤0.001%
(p-chloroacetanilide )
ND
Individual unspecified impurity:≤0.05%
0.001%
Total impurities:≤0.1%
0.017%
Assay:
98.0~102.0%
HPLC method
99.6%
Bacterial Endotoxins
≤0.0875EU/mg
EP2.6.14 Method A
<0.0875EU/mg
Microbial Analysis
Total Aerobic Microbial Count:≤1000CFU/g
EP2.6.12
<10CFU/g
Residual Solvents:
Glacial acetic acid is used in Acetaminophen production, and it can be determined by Loss on Drying not more than 0.5%
Conclusion:
It conforms to USP 42.
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