Items
Standards
Characteristics
A white crystalline powder, soluble in formic acid, sparingly soluble in water, very slightly soluble in ethanol(95%) and practically insoluble in acetonitrile
Identifications
A) IR spectrum
B) Chloride
Clarity and color of solution
A 5% aqueous solution is clear colorless
Loss on drying
0.3%max
Sulfate
0.048%max
Heavy metals
10ppm max
Residue on ignition
0.10%max
Ph(5% aqueous solution)
4.0-5.0
Related compounds(by HPLC)
Impurity a(‘):0.20%max
Each other impurity: 0.20%max
Total impurities: 0.50%max
Assay(by titration)
99.0-101.0%