Ketoprofen
|
Test items |
Specification |
Results |
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|
Appearance |
White or almost White crystalline powder |
White crystalline powder |
|
|
Solubility |
Practically insoluble in water,freely soluble in acetone,in ethanol(96 per cent) and in methylene chloride |
Meets |
|
|
Identification |
IR Absorption |
IR spectrum of sample is the same with USP CRS spectrum |
Meets |
|
|
UV Absorption |
Absorptivities at the wavelenght of maximum absorbance at about 258nm do not differ by more than 3.0% calculated on the sried basis. |
Meets |
|
Melting Range |
92.0℃-97.0℃ |
95.5℃-96.0℃ |
|
|
Specific rotation |
+1°~ -1° |
+0.1° |
|
|
Loss on drying |
0.5%Max |
0.13% |
|
|
Residue on Ignition |
0.2%Max |
0.06% |
|
|
Chromatographic Purity Single impurity Total impurity |
0.2%Max 1.0%Max |
0.11% 0.18% |
|
|
Assay |
98.5%-101.0% |
99.7% |
|
|
Residue solvents |
Methanol |
3000ppm Max |
ND |
|
|
Ethanol |
5000ppm Max |
82ppn |
|
|
Benzene |
2ppm Max |
ND |
|
|
Toluene |
890ppm Max |
ND |
|
Conclusion |
Complies with USP43 |
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