Product   Name:

Cipfloxacin   Base

Ciprofloxacin   Lactate

Ciprofloxacin   Hydrochloride

Synonyms:

Cipfloxacine,

Ciprofloxacini

Ciprofloxacini   Lactate

Ciprofloxacin   Hcl,

Ciprofloxacini   hydrochloridum

CAS:

85721-33-1

97867-33-9

86483-48-9

or 86393-32-0

Appearance:  

White   crystalline powder

White   powder or crystalline powder

A   pale yellow, crystalline powder, soluble in water

Assay:  

98.0%-102.0%

98.5%   Min

98%  ~ 102%

Formula:

C17H18FN3O3

C20H22FN3O5

C17H18FN3O3,HCl,H2O 

Structure:  

Package:

25Kg/Drum

Name of Product

Ciprofloxacin base

Testing   Item

Standard

Result

Appearance

White crystalline powder

Clarity of solution

Meet the requirements

Meets the requirements

Loss on drying

≤1.0%

0.2%

Residue on ignition

≤0.2%

0.12%

Heavy metals

≤0.002%

≤0.002%

Sulfate

Chloride

≤0.04%

≤0.04%

＜0.04%

<0.02%

Fluoroquinolonic acid

Meet the requirements

Meets the requirements

Ciprofloxacin ethylenediamine anlog

≤0.2%

0.05%

Any other individual impurity

≤0.2%

0.03%

Total impurities

≤0.5%

0.14%

Assay (on the anhydrous basis)

98.0%-102.0%

Ciprofloxacin Base

100.9%

Name   of Product

Ciprofloxacin   Lactate

Testing Item

Standard

Result

Appearance  

Almost   white or light yellow crystalline powder; Odorless and bitter, hygroscopicity

Complies

Identification A

Bismuth potassium Iodide solution   test: Solution shows brownish red.

Complies

Identification B

UV: Absorption max at 277nm

Complies

Identification C

IR: Conforms to the reference spectrum

Complies

Identification D

Lactate Test: Positive

Complies

pH

4.5   ~ 5.5

4.9

Clarity of solution

Clear

Clear

Color   of solution

Absorption   at 430nm ≤0.05

0.03

Fluoride

≥   4.2%

4.5%

Related   Substances

Individual   Impurity ≤0.5%

Total   Impurities ≤1.0%

<   0.5%

<   1.0%

Loss   on drying (60 °C)

≤   6.5%

4.4%

Residual on Ignition

≤   0.1%

0.08%

Heavy   Metal

≤   20ppm

<   20ppm

Assay   (Ciprofloxacin Lactate)

≥   98.5% on dried basis

98.9%

Name   of Product

Ciprofloxacin   Hcl or Ciprofloxacin Hydrochloride

Testing Item

Standard

Result

Characters

Faintly   yellowish to light yellow crystals

Complies

Identification   A

IR   Spectrum of sample complies with the reference standard

Complies

Identification   B

HPLC:   The retention time of the major peak of the sample solution corresponds to   the one of standard solution, as obtained in the assay

Complies

Identification   C

Show   reaction of chlorides.

Complies

pH

3.0   ~ 4.5

3.7

Water

4.7%   ~ 6.7%

5.3%

Residue   on ignition

≤   0.1%

0.05%

Heavy   metals

≤   20ppm

<   20ppm

sulfate

≤   0.04%

<   0.04%

Fluoroquinolonic   acid

≤   0.2%

Complies

Ciprofloxacin   ethylenediamine

≤   0.2%

0.04%

Any   other individual impurity

≤   0.2%

0.05%

Total   impurities

≤   0.5%

0.18%

Ethanol

≤   4000ppm

426ppm

Isoamyl   Alcohol

≤   4000ppm

Not   detected

Assay   (on the anhydrous basis)

98.0%   ~ 102.0%

Ciprofloxacin   Hydrochloride (Ciprofloxacin Hcl)

99.4%