Raw material Ciprofloxacin Hcl BP/USP/EP

Items of Test

Standard

Result of Test

Appearance

White or light yellow crystalline powder

conform

Identification

(a)   IR

 

(b)   TLC

 

 

(c) the reaction of chloride

 

IR spectrum of sample corresponds to that of reference standard.

The intensity and RF value of the principal band obtained from the test solution corresponds to that obtained from the standard solution.

A solution of IIresponds to the tests of chloride

 

Conform

 

Conform

 

 

Conform

Related substances HPLC

Chromatographic purity ≤ 0.2%

Ciprofloxacin ethylenediamine analog ≤ 0.2%

Unspecified impurity ≤ 0.*0%

Total impurities ≤ 0.5%

0.*5%

<0.*1%

0.*0%

Ph

3.**4.5

3.7

Heavy metals

≤*0ppm

<*0ppm

Fluoroquinolonic acid

≤0.2%

Conform

Sulphated ash

≤0.*4%

<0.*4%

Water

4.7%*6.7%

5.*0%

Residue of ignition

≤0.1%

0.*5%

Residual solvent

ethanol ≤ ***0ppm

Isoamyl alcohol≤ ***0ppm

**0ppm

Not found

Assay (HPLC)

*8.0%***2%

*9.8%