Superiority:
Appearance White or almost white crystalline powder, Slight special smell, taste bitter
Identification a. Infrared absorption spectrophotometry
b. It gives reaction(a) of sodium
Color of solution 3 max
Clearity of solution 1 max
PH 4.5-6.5
Specific optical rotation +223? ~ +237?
Related substance 2-amino-3-methyl-Asiannmethyl butyric acid: 0.5% max
6 - aminopenicillanic acid: 0.1% max
0.8% max(Total)
2 - ethylhexanoate 0.5% max
Water 1.0% max
Bacterial endotoxins Complies with requirement
Sterility Confirm
Assay(on dry base) 88.6%min
Conclusion The above result complies with CP2010
Details:
Appearance White or almost white crystalline powder, Slight special smell, taste bitter
Identification a. Infrared absorption spectrophotometry
b. It gives reaction(a) of sodium
Color of solution 3 max
Clearity of solution 1 max
PH 4.5-6.5
Specific optical rotation +223? ~ +237?
Related substance 2-amino-3-methyl-Asiannmethyl butyric acid: 0.5% max
6 - aminopenicillanic acid: 0.1% max
0.8% max(Total)
2 - ethylhexanoate 0.5% max
Water 1.0% max
Bacterial endotoxins Complies with requirement
Sterility Confirm
Assay(on dry base) 88.6%min
Conclusion The above result complies with CP2010