Zoledronic Acid By Fuhuiyuan Industrial Co. Limited

Item

Specification

Result

Appearance

White or almost white crystalline powder

White crystalline powder

Solubility

Practically insoluble in ethanol, slightly soluble in water, sparingly soluble in NaOH(0.1M)

Conforms

Identification

IR: absorption spectrum should be consistent with the spectrum obtained with that of the RS.

Conforms

The retention time of principal peak in chromatogram obtained with the test solution is identical with that obtained with reference solution

Conforms

It gives reaction of phosphate

Conforms

Clarity and color of solution

The solution should be clear and colorless, if not, not more inrensely turbid than No.1 reference solution and not more intensely colored than reference solution of yellow-2.

Conforms

pH

2.0-3.5

2.9

Residue solvents

n-hexane 0.029% max(g/g)

0.000039%

Acetonitrile 0.041% max(g/g)

Undetectable

Chlorobenzene 0.036% max(g/g)

Undetectable

Phosphate

0.4% max

Conforms

Phosphite

0.4% max

Conforms

Chloride

0.04% max

Conforms

Loss on drying

5.5-7.5%

6.3%

Heavy metals

10ppm max

Conforms

Related substances

Any other single impurity:0.5% max

0.27%

Total impurity:1.0% max

0.50%

Assay

98.5% min(on dried basis)

99.6%

Microbial limit

Total aerobic microbial count:1000cfu/g max

10cfu/g

Total combined yeast/molds count:100cfu/g max

10cfu/g

Escherichia coli: absent

undetectable

Conclusion:The batch tested complies with the standard .