| THERAPEUTIC CATEGORY |
Anti-Bacterial |
| CHEMICAL NAME |
1- CYCLOPROPYL -6- FLUORO,
4- DIHYDRO -4- OXO -7- (1-PIPERAZINYL)-3-QUNOLINE -
CARBOXYLIC ACID MONO
HYDROCHLORIDE,MONOHYDRATE. |
| SOLUBILITY |
Sparingly soluble in water and slightly soluble in Methanol. |
| DESCRIPTION |
Faintly yellowish to light yellowish crystals |
| IDENTIFICATION |
a) IR - As per USP
b) TLC - As per USP
c) Chloride - As per USP |
| pH of 1 in 40 solution |
3.0 - 4.5 |
| WATER (BY KF) |
4.7% - 6.7% |
| RESIDUE OF IGNITION |
Notmore than 0.1%. |
| RELATED SUBSTANCES (BY HPLC) |
Not more than 2.0% |
| LOSS OF DRYING. |
Not more than 2.0%. |
| UV-ABSORBANCE |
Exhibits a maximum at 277nm, in 0.1N HCL solution in UV range, with
concentration being 5 mcg. per ml. |
| SULPHATE |
Not more than 0.04% |
| HEAVY METALS |
Not more than 0.002% |
| LIMIT OF FLUROQUINOLONIC ACID (TLC) |
As per USP standards. |
CHROMATOGRAPHIC PURITY
|
Min 99.5%
a) Not more than 0.2% of ciprofloxacin ethylene diamine analog.
b) Not more than 0.2% of any other impurity, and
c) The sum of all impurity peaks, not more than 0.5% |
ASSAY CALCULATED ON
ANHYDROUS BASIS.
|
Not less than 98.0% and not more than
102.0% |
STORAGE
|
In tightly closed container in a cool dry place and protected from light. |
| SHELF LIFE |
5 years if stored under suitable conditions. |
| STANDARD PACKING |
In 25kg new Fibre drums or HDPE drums. |
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