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Norfloxacin is a synthetic chemotherapeutic antibacterial agent occasionally used to treat common as well as complicated urinary tract infections. It is sold under various brand names with the most common being Noroxin.
Specification:
|
TEST |
SPECIFICATION |
RESULT |
|
|
Description |
White to pale yellow,hydroscpion, photosensitive, crystalline powder |
Complies |
|
|
Identification |
IR |
Complies |
|
|
Appreance of solution |
Complies |
Complies |
|
|
Related Substances |
Impurity E |
max.0.1% |
0.01% |
|
Methyl-Norfloxacin |
max.0.15% |
0.08% |
|
|
Unspecicifed Impurities |
max.0.1% |
0.04% |
|
|
Total Impurities |
max.0.5% |
0.2% |
|
|
Loss on drying |
max.1.0% |
0.3% |
|
|
Residue on ignition |
max.0.1% |
0.05% |
|
|
Heavy metals |
max.15ppm |
10ppm |
|
|
Purity chromatographic |
The sum of all impurities’peaks is not more than 0.5% |
Complies |
|
|
Assay |
99.0%-101.0% |
99.8% |
|
|
Residual Solvents Ethanol |
max.5000ppm |
Not detected |
|
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
