Characters White or almost white powder, Hygroscopic
Identification A: Conforms with reference Rf.(TLC)
B: Conforms with reference
Standard retention time.(HPLC)
Water 7.5% max
pH 9.0~11.0
Residue on ignition 1.0% max
metals 0.003% max
TLC Chromatographic purity 1.0% max
Assay ≥910ug/mg(on anhydrous basis)
Bacteria endotoxin ≤2.0EU/mg
Solution clear degree and color Clear, not more than 3 bugle yellow
Residual solvents Ethanol not more than 2000ppm
Microbiological purity Not more than 1000 aerobic bacteria per 1g
Not more than 100 fungi per 1g
Absence of Escherichia coli per 1g
