Lomefloxacin Hcl CP / In-house standard

Items

Specification

Results

Characters  

A white or almost white crystalline powder; almost odourless. Slightly soluble in water, practically insoluble in methanol and in ethanol, freely soluble in sodium hydroxide TS, very slightly soluble in dilute hydrochloride acid.

A white or almost white crystalline powder; almost odourless. Slightly soluble in water, practically insoluble in methanol and in ethanol, freely soluble in sodium hydroxide TS, very slightly soluble in dilute hydrochloride acid.

Identification 

The retention time of the principal peak in the chromatogram of the test solution obtained in the assay is identical with that of lomefloxacin CRS in the chromatogram of the reference solution.

Conform

The light absorption should exhibits a maximum at 287nm

The light absorption exhibits at 288nm

The infrared absorption spectrun should accordant with the reference spectrum

accordant with the reference spectrum

Should be positive reaction

positive reaction

Acidity

PH should 3.5-4.5

3.7

Clarity of solution

Should confirm the specification

Conform

Absorbance

Should confirm the specification

Conform

Related Substances

Single impurity not more than 0.5%

0.06%

Total impurities not more than 1.0%

0.091%

Loss on drying 

Not more than 0.5%

0.06%

Residual on ignition

Not more than 0.1%

Conform

Heavy metals

Not more than 20ppm

Conform

Residual solvents

Ether,ethanol and acetone Should confirm the specification

Conform

Assay

Calculated as dried basis, C₁₇H₁₉F₂N₃O₃ should not less than 89.2%

89.7%

Microbial Limit

TAMC not more than 1000cfu

TYMC not more than 100cfu

E.Coli should not be detected

Conform

Conform

ND