|
PRODUCT NAME: NORFLOXACIN (NORFLOXACINO) USP39 EXPIRY DATE: 4 YEARS CAS NUMBER: 70458-96-7 |
||
|
Item |
Specification |
|
|
Description |
White to pale yellow crystalline powder, sensitive to light and moisture. |
|
|
Solubility |
Slightly soluble in acetone, in water, and in alcohol; freely soluble in acetic acid, sparingly soluble in chloroform; very slightly soluble in methanol and in ethyl acetate; insoluble in ether. |
|
|
Appearance of solution |
≤ SoI.II ≤ B7 |
|
|
Identification |
(A) IR absorption-positive (B) The retention time of the major peak of the Sample solution corresponds to that of the standard solution, as obtained in the Assay. |
|
|
Related substances |
Impurity K |
≤0.15% |
|
Impurity E |
≤0.15% |
|
|
Impurity A |
≤0.10% |
|
|
Impurity H |
≤0.10% |
|
|
Unidentified |
≤0.10% |
|
|
Total impurities |
≤0.5% |
|
|
Heavy metals |
≤0.0015% |
|
|
Residual solvents |
Ethanol ≤0.5% |
|
|
Loss on drying |
≤1.0% |
|
|
Residue on ignition |
≤0.1% |
|
|
Content (on dry basis) |
98.0%~102.0% |
|
|
Conclusion: Complies with USP39. |
||
