Ciprofloxacin lactate 5fmdma2201 sodium carbonate
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TESTS |
ACCEPTANCE CRITERIA |
RESULTS |
CHARACTERS |
ALMOST WHITE OR LIGHT YELLOW CRYSTALLINE POWDER |
CONFORMS
|
ODORLESS AND BITTER ,HYGROSCOPICITY |
||
IDENTIFICATION |
(1) BISMUTH POTASSIUM IODIDE SOLUTION TEST: SOLUTION SHOWS BROWNISH RED COLOUR. |
CONFORMS |
(2)UV:ABSORPTION MAXIMUM AT.277nm |
||
(3)IR:CONFORMS TO THE REFERENCE SPECTRUM |
||
(4)RESPONDS TO THE TESTS FOR LACTATE |
||
PH |
4.5-5.5 |
4.9 |
CLARITY |
CLEAR |
CONFORMS |
COLOUR |
ABSORBANCE≤0.05,AT 430nm |
0.01 |
FLUORIDE |
≥4.2% |
4.5% |
RELATED SUBSTANCES (HPLC) |
INDIVIDUAL IMPURITY≤0.5% TOTAL IMPURITIES≤1.0% |
CONFORMS |
LOSS ON DRYING |
≤6.5%(60°C) |
3.6% |
RESIDUE ON IGNITION |
≤0.1% |
0.06% |
HEAVY METALS |
≤20ppm |
<20ppm |
ASSAY |
CONTENT C17H18FN3O3·C3H6O3(on dried basis) ≥98.5% |
99.2% |
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