| Name of the Product |
: |
Omeprazole enteric coated pellets |
| INN Name |
: |
Omeprazole |
| Chemical Name |
: |
5 methoxy-2-(((4 methoxy-3,5-dimethyl-2-pyridiyl) sulfiny)-1H-benzimidazole |
| Molecular formula |
: |
C17H19N3O3S |
| Molecular weight |
: |
345.4 |
| Packing |
: |
Black Polythene bag lined fibre board/HDPE drums |
| Identification |
: |
Should comply with the test |
| Water (by KF) |
: |
Not more then 2.0% w/w |
|
| Dissolution |
| Acid media |
: |
Not more then 10.0% in 2 hrs |
| Buffer media |
: |
Not less than 90.0% in 45 minutes |
|
| Assay |
: |
Not less than 90.0% and more than 110.0% |
|
| Additional Tests |
| Bulk Density |
|
| *Tapped |
: |
0.65 to 0.85 |
| *Untapped |
: |
0.55 to 0.70 |
| *Mesh size |
: |
100% passed through 16 mesh |
|
