Product Name: ENROFLOXACIN BASE

Characters

Appearance

Yellowwish or light orange-yellow，crystalline powder

Yellowwish crystalline powder

Melting point

221~226℃

223.5~225.5℃

Identification

（1）HPLC

The retention time of the major    peak of the sample solution correspond to that of the standard solution，as obtained in the assay. 

Conforms

（2）IR

The spectrum of sample conforms    to that of the reference spectrum.

Conforms

Tests

Appearance of solution

The solution is not more opalescent than    reference suspension I and not more intensely coloured than reference    solution Y4 or GY4.

Conforms

Fluoroquinolonic acid

Not more than 0.2%

Conforms

Related substances

Ciprofloxacin

Not more than 0.5%

0.07%

Unspecified impurity

Not more than 0.3%

0.2%

Total impurity

Not more than 0.7%

0.3%

Loss on drying

Not more than 0.5%

0.07%

Residue on ignition

Not more than 0.2%

0.05%

Heavy metals

Not more than 0.002%

Less than 0.002%

Assay(on dried substance)

Not less than 99.0% of C19H22FN3O3

99.5%