| Synonyms |
Sodium5-methoxy-2[{(4-methoxy3,5-dimethyl pyridin-2-yl) methyl} sulphinyl]- 1H- Benzimidazole |
Molecular Formula
|
C17H18N3NaO3S,H20 |
| Molecular Weight |
385.4 |
| CAS Number |
95510-70-6 |
| S. No. |
Test |
Specification |
| 1 |
Characteristics |
A white or almost white powder, hygroscopic, freely soluble in water and in alcohol, soluble in propylene glycol, very slightly soluble in methylene chloride |
| 2 |
Identification |
|
|
A |
The ratio of the absorbance measured at the maximum at 305nm to the maximum 276nm is 1.6 to 1.8 |
| B |
The prinicipal spot in the chromatogram obtained with test solution (b) is similar in position and size to the principal spot in the chromatogram obtained with reference solution (a) |
| C |
The spots should be turn brown |
| 3 |
Appearance of solution |
2. 0% solution in water (solution) is clear and not more intensely coloured than reference solution b6 |
| 4 |
pH |
10.3 to 11.3 |
| 5 |
Omeprazole impurity-C |
Any spot in the chromatogram obtained with test solution (a) with a higher Rt value than that of the spot corresponding to omeprazole is not more intense than the spot in the chromatogram obtained with solution(b) (0.1%) |
| 6 |
Heavy metals |
Not more than 10 ppm |
| 7 |
Related substances |
The area of any peak, apart from the principal peak, in the chromatogram obtained with test solution is not greater than the area of the peak in the chromatogram obtained with the reference solution (b) (0.1%) |
| 8 |
Water |
Between 4.5% to 10.0% |
| 9 |
Assay (% by mass) |
Omeprazole sodium contains not less than 98.0% and not more than 101.0% as on dried substances. |
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