|
| TEST |
SPECIFICATION |
|
| Identification HPCL |
The retention time of clarithromycin peak III the chromatogram of test solution should correspond to that of the reference solution as obtained in the assay.
|
|
| Particle Size |
Minimum 90% should pass through 30# |
|
| Los on drying |
Not more than 5.0% w/w at 105 °c. |
|
| Residue on ignition |
Not more than 0.5% w/w |
|
| Heavy Metals |
Not more than 20 ppm |
|
| Dissolution in 0.1 NHCI |
Not more than 10% of clarithromycin is released in 60 minutes |
|
| Dissolution III PH phosphate buffer |
Not less than 75% of clarithromycin is dissolved in 60 minutes |
|
| Assay (HPLC) |
Not less than 260 mcg / mg and not ,ore than 300 mcg / mg of clarithromycin |
|
| DISSOLUTION |
NLT -- 85%
60 Mins in 0.1M Hcl |
|
ASSAY
Itraconazole 22% |
20.9%--23.10% |
|
