Tests

Acceptance Criteria

Results

Characters

Almost white to light yellow crystalline powder

Conforms

odorless and little bitter

Identification

(1)Malonic acid / acetic anhydride test : Solution shows brownish red colour..

Conforms

(2)Sodium hydroxide–copper sulphate solution: blue precipitation

(3)UV: Absorption maxima at. 271nm,323nm,335nm

(4)IR: Conforms to the reference spectrum

Clarity

Clear or not more opalescent than reference suspension II

Conforms

Fluoride

≥4.0%

4.2%

Related substances

Spots of test solution correspond to that of reference solution of nicotinic acid

Conforms

Spots of test solution correspond to that of reference solution of Norfloxacin

The intensity of spots of impurities is not greater than that of the reference solution

Loss on drying

≤3.0%  (105°C)

2.1%

Residue on ignition

≤0.2%

0.06%

Heavy metals

≤ 20ppm

<20ppm

Assay

≥98.0%  (C₁₆H₁₈FN₃O₃·C₆H₅NO₂On dried basis)

99.6%