Appearance: White or off-white crystalline powder
Solubility: Easily soluble in water, Soluble in methanol
It was tested according to SFDA’s standard YBH01832010.
Identification:
UV: Meets the requirements
IR: Consistent with reference spectrum
Chemical reaction: Meets the requirements
Acidity: 4.5-6.0
Appearance of solution:
Color: not more intensely coloured than reference solution Y1 (yellow No.I )
Clarity: not more palescent than reference suspension solution I
Related substances:
Single impurity: 0.1%max
Total impurities: 1.0%max
Dimethylformamide ( DMF): 0.088%max
Aether: 0.5%max
Methanol: 0.3%max
Dichloromethane: 0.06%max
Moisture: 2.5%max
Residue on ignition: 0.1%max
Heavy metals: 0.002%max
Assay: 99.0%min
Package: 1kg/Aluminum foil bag
Certification: GMP, ISO9001:2008, ISO14001:2004
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