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Ciprofloxacin Hcl

CAS number: 93107-08-5

Molecular formula:

molecular weight:

Chemical structure:

Details

PRODUCT NAME: CIPROFLOXACIN HCL
Shelf Life
3 years
SPECIFICATION: 
USP 38
Items
Specification Results
Appearance Faintly yellowish to light yellow crystals.
Faintly yellowish crstals
IDENTIFICATION
A. IR
IR spectrum of sample conforms to that of reference standard. Complies
B. HPLC
The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay.
Complies
C. Reaction of chlorides A solution of it responds to the tests for Chloride Complies
ASSAY(on anhydrous basis) 98.0% ~ 102.0% of C17H18FN3O3•HCl
100.5%
Impurities
Inorganic Impurities

Residue on ignition Not more than 0.1% 0.01%
Chloride and Sulfate
Sulfate
Not more than 0.04% Less than 0.04%
Heavy metals Not more than 0.002% Less than 0.002%
Organic Impurities
Fluoroquinolonic acid (Method 1) Not more than 0.2% Less than 0.2%
Ciprofloxacin ethylenediamine analog (Method 2) Not more than 0.2% 0.09%
Any other Individual impurity (Method 2) Not more than 0.2%

0.08%(RRT:0.4)

0.05%(RRT:0.8)

0.06%(RRT:2.2)

Total impurities (Method 2) Not more than 0.5% 0.41%
pH 3.0 ~ 4.5 3.9%
Water 4.7% ~ 6.7% 5.9%
Residual solvents
Ethanol Not more than 4000ppm 54ppm