Product

Ofloxacin

Levofloxacin Hemihydrate

Synonyms:

Ofloxacinum, Ofloxacine

Levofloxacine

CAS

82419-36-1

138199-71-0

Appearance:

A pale yellow or bright yellow, crystalline   powder

Yellowish crystalline powder

Assay

98.5% ~ 101.5%

98.5% Min

Formula:

C18H20FN3O4

C18H20FN3O4·1/2H2O

Structure:

Packing info

25Kg/Cardboard Drum

25Kg/Cardboard Drum

Name of product

Ofloxacin

Analytical items

Specifications

Analytical results

Characteristics

White or Light yellow green   crystalline powder

Complies

Identification

A: IR test

B:   UV test

Complies

Complies

Specific rotation

D20

-1°~+1°

+0.26°

Residual Solvents

A: Methanol

B: Ethanol

≤0.005%

≤0.05%

＜0.005%

＜0.05%

Purity test (HPIC)

A: Individual impurity

B: 9-desfluoroofloxacin

C: Total   impurity

≤0.3%

≤0.2%

≤0.5%

0.11%

0.09%

0.23%

Heavy metals

≤0.001%

＜0.001%

Arsenic

≤1ug/g

Complies

Assay (on the dried basis)

≥98.5%

99.2%

ITEMS

STANDARD

RESULTS

Appearance

Yellowish   crystalline powder

Yellowish   crystalline powder

Specific   optical rotation

-92°—   -99°

-97.2°

Identification    IR

IR   spectrum of sample conforms to that of reference standard.

complies

Identification    HPLC

The   retention time of the major peak in the chromatogram of the sample correspons   to that of reference standard.

complies

PH   of solution

6.8~7.6

7.0

Clarity   of solution

Clear   or its opalescence is not more pronounced than that of reference suspension   1.0

Clear

UV   absorbance

≤0.05

0.002

Water

2.1%~2.7%

2.7%

Impurity   A

≤0.2%

＜0.2%

Impurity   B

≤0.2%

0.07%

Impurity   C

≤0.2%

Not   found

Any   other impurity

≤0.1%

0.05%

Sum   of impurities

≤0.5%

0.14%

R-ofloxacin

≤0.5%

0.22%

Ethanol

≤0.1%

0.062%

DMSO

≤0.1%

Not   found

Chloroform

≤0.006%

0.0057%

Residue   on ignition

≤0.1%

0.04%

Heavy   metals

≤10   ppm

3ppm

Assay   (on anhydrous basis)

98.0%~102.0%   C18H20FN3O4

99.5%