Powder: | Yes |
---|---|
Customized: | Non-Customized |
Certification: | GMP, ISO 9001, USP |
State: | Solid |
Purity: | >99% |
Product Name: | Paracetamol |
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Tests
|
Standards
|
Results
|
Appearance
|
White or almost white,crystalline powder.
|
White,crystalline powder.
|
|
A:IR absorption
|
Complies
|
B:UV absorption
|
Complies
|
|
C:TLC
|
Complies
|
|
Melting point
|
168~172ºC
|
169.0~170.9°C
|
Water
|
Not more than0.5%
|
0.0008
|
Related substance
|
ImpurityJ(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%
|
0.0001
|
|
Total of other impurities not more than 0.1%
|
0.0002
|
|
Residue on ignition
|
Not more than 0.1%
|
0.0005
|
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 content of acetic acid is limited by the test of loss on dryingnot more than0.5% |
0.0008
|
Assay(anhydrous basis)
|
99.0~101.0%
|
0.996
|
Conclusion
|
Complies with USP34/ BP2011
|
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