Product name: Gatifloxacin mesylate
CAS NO: 160738-57-8
(GYZZH20030878 )
C₁₉H₂₂FN₃O₄·CH₃SO₃   471 . 50

 

[Property]This product is white or off-white powder;
Odorless, bitter taste.

 

[Identification].
（1）The infrared light absorption pattern of this product should be consistent with that of the reference product of Gatifloxacin mesylate.

(2) In the chromatogram recorded under the content determination item, the retention time of the main peak of the test sample should be consistent with the retention time of the main peak of the Gatifloxacin mesylate reference substance.

 

[Inspection].
Acidity pH value should be 3.0~4.5.

Clarity and color of the solution should not be more concentrated than the No. 2 turbidity standard if it is turbid, and if it is colored, it should not be darker than the yellow or yellow-green No. 6 standard colorimetric solution.

Relative substance shall not exceed 1.0%.

Moisture should not exceed 1.0%.

Residue on ignition shall not exceed 0.2%.

Heavy metals shall not exceed 10 parts per million

Residual solvent  Toluene must not exceed 0.089%, ethanol must not exceed 0.5%

 

[Content determination] According to the calculation of anhydrous, the content of gatifloxacin (C₁₉H₂₂FN₃O₄) shall not be less than 78.4%.