Original
By certification 
Norfloxacin Nicotinate CAS 118803-81-9 and Norfloxacin Hydrochloride CAS 68077-27-0 and Norfloxacin Lactate CAS 97867-34-0 
Product |
Norfloxacin Nicotinate |
Norfloxacin Hydrochloride |
Norfloxacin Lactate |
Synonyms: |
Norfloxacine Nicotinate |
Norfloxacin Hcl |
Norfloxacine Lactate |
Characteristics: |
Almost white slightly yellowish crystallne powder |
White to slightly yellow crystalline powder. |
White powder. |
CAS |
118803-81-9 |
68077-27-0 |
97867-34-0 |
Assay: |
98% Min |
98.5% Min |
99% Min |
Formula: |
C22H23FN4O5 |
C16H18FN3O3 |
C16H18FN3O3·C3H6O3 |
Structure: |
|
|
|
Package |
25Kg/Drum |
25Kg/Drum |
25Kg/Drum |
COA—Norfloxacin Nicotinate
Name of Product |
Norfloxacin Nicotinate |
|
Testing Item |
Standard |
Result |
Appearance |
Almost white slightly yellowish crystallne powder |
Complies |
|
Identification |
(1)Malonic acid/Acetic Anhydride test: Solution shows brownish red colour. |
Complies |
(2)Sodium Hydroxide-copper sulphate solution: Blue precipitation |
Complies | |
(3)UV: Absorption maxima at 271nm, 323nm, 335nm |
Complies | |
(4)IR: Conforms to the reference spectrum |
Complies | |
|
Clarity of solution (0.5g/10ml water) |
Clear or not more opalescent than reference suspension II. |
Complies |
Fluoride |
≥ 4.0% |
4.2% |
|
Related substances |
Spots of test solution correspond to that of reference solution of nicotinic acid |
Complies |
Spots of test solution correspond to that of reference solution of Norfloxacin |
Complies | |
The intensity of spots of impurities is not greater than that of reference solution |
Complies | |
Loss on drying |
≤ 3.0% (105°C) |
2.5% |
|
Assay (Norfloxacin nicotinate) |
≥ 98% (On dried basis) |
98.3% |
COA—Norfloxacin Hydrochloride (Norfloxacin Hcl)
Name of Product |
Norfloxacin Hcl |
|
Testing Item |
Standard |
Result |
Appearance |
White to slightly yellow crystalline powder |
Complies |
Clarity of solution |
Clear or opacity not more than reference suspension 2 |
Complies |
Fluoride |
≥ 5.0% |
5.2% |
Related Substance |
The spots obtained from the test solution are not more than there, and not more intensly than the principle spot obtained from the standard solution. |
Complies |
Loss on drying |
≤ 2.0% (105 °C) |
0.06% |
Residue on ignition |
≤ 0.2% |
0.02% |
|
Assay (Norfloxacin Hydrochloride) |
≥ 98.5% (On dried basis) |
99.2% |
