Test Items
Specification
Test Results
Appearance
White powder
White powder
Melting point
125~127°C
Conforms
Specific Rotation
+28°~+30°
+29°
Acidity(PH)
5.2~6.5
5.8~6.2
Water
4.0%~5.5%
5.0%
Residue On Ignition
Not more than 0.1%
Conforms
N.N – dimethylaniline
Comply with the standard
Conforms
Phenolic Compounds
Comply with the standard
Conforms
Related Substance
Comply with the standard
Conforms
Assay
Between99.0~102.0%
99.53%
Conclusion
This batch is complies with USP 41
URl: