Product

CIPROFLOXACIN HCL

Packing

        25 Kg / drum

Batch No.

HB00N100794

Analytic date

    Aug.23,2010

Mfg date

           Aug.22,2010

Expiry date

        Aug.22,2013

Test Items

Quality requirement

Test results

Characteristics

Faintly yellowish to light yellow crystals

Faintly yellowish crystals

Identification

Meet the requirements

Meets the requirements

pH

3.0 ~ 4.5

3.7

Water

4.7 %~6.7%

5.8%

Residue on ignition

≤0.1%

0.03 %

Heavy metals

≤20ppm

<20ppm

Sulfate

≤0.04%

<0.04%

Fluoroquinolonic acid

≤0.2%

Meets the requirements

Ciprofloxacin ethylenediamine analog

≤0.2%

0.04%

Any other individual impurity

≤0.2%

0.06%

Total impurities

≤0.5%

0.17%

Assay(on the anhydrous basis)

98.0%~102.0%

100.4%

Conclusion

Meet the requirements of USP32