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tem
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Standard
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Result
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Characters
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White crystalline powder
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White crystalline powde
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Solubility
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1g of the specimen dissolves in 20ml boil water, 15ml 1mol/L sodium hydroxide solution, freely soluble in alcohol.
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Conforms
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Identification
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A:Melting range 168-172℃
B.C.D.E Positive
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169.6-170.3℃
B.C.D.E Positive
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|
Related subtances
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Impurity J(chloracetanilide)≤10ppm
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<10ppm
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Impurity K(4-aminophenol)≤50ppm
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<50ppm
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Impurity F(4-nitrophenol)≤0.05%
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<0.05%
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Any other impurity≤0.05%
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<0.05%
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Total of other impurity ≤0.1%
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<0.1%
|
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Chloride
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≤0.014%
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<0.014%
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Sulfate
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≤0.02%
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<0.02%
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Sulfide
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Complies
|
Complies
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Heavy metals
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≤0.001%
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<0.001%
|
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Free p-Aminophenol
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≤0.005%
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<0.005%
|
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Chloracetanilide
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≤0.001%
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<0.001%
|
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Readily carbonizable substances
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Complies
|
Complies
|
|
Residual solvent
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Residual content of acetic acid ≤0.5%
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<0.11%
|
|
Organic volatile impurities
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Complies
|
Complies
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|
Water
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≤0.5%
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0.11%
|
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Residue on ignition
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≤0.1%
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0.03%
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Assay
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99.0-101.0%(Dried substance)
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100.2%
|
|
Conclusion
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It complies with requirements of the BP2012/USP35
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