Superiority:
Appearance White or almost white powder, very hydroscopic, slightly soluble in ethanol. It shows polymorphism.
Identification a. Infrared absorption spectrophotometry
b. It gives reaction(a) of sodium
Appearance of solution Clear
PH 4.0-6.0
Specific optical rotation -15? ~ -24?
Absorbance 260-300
Related substance 1.0% max(Single)
3.5% max(Total)
N,N-Dimethylaniline 20ppm max
Water 6.0% max
Bacterial endotoxins 0.15IU/mg max
Sterility Confirm
Assay(on dry base) 95.0-102.0%
Conclusion The above result complies with EP 7.0
Details:
Appearance White or almost white powder, very hydroscopic, slightly soluble in ethanol. It shows polymorphism.
Identification a. Infrared absorption spectrophotometry
b. It gives reaction(a) of sodium
Appearance of solution Clear
PH 4.0-6.0
Specific optical rotation -15? ~ -24?
Absorbance 260-300
Related substance 1.0% max(Single)
3.5% max(Total)
N,N-Dimethylaniline 20ppm max
Water 6.0% max
Bacterial endotoxins 0.15IU/mg max
Sterility Confirm
Assay(on dry base) 95.0-102.0%
Conclusion The above result complies with EP 7.0