| Synonyms |
(RS)-5-methoxy-2-[[(4-methoxy-3,5-dimethyl Pyridin-2-yl) methyl] Sulphinyl]-1H- Benzimidazole |
Molecular Formula
|
C17H19N3O3S |
| Molecular Weight |
345.42 |
| CAS Number |
73590-58-6 |
| S. No. |
Test |
Specification |
| 1 |
Characteristics |
A white or almost white powder. Very slightly soluble in water soluble in ethanol (96%) in methanol and in dichloromethane. It dissolves in dilute solutions of alkali hydroxides. |
| 2 |
Identification |
|
|
A) Ultra Violet
Absorption |
The Ratio of the abosrbance measured at the maximum 305nm to the maximum at 276nm is 1.6 to 1.8 |
| B) Infra Red Absorption |
The infrared absorption spectrum of a potassium bromide dispersion of it exhibits maxima at the same wavelengths as that of a similar preparation of Omeprazole CRS. |
| C) TLC |
Examine by thin layer chromatography. |
| 3 |
Melting range in degree centrigrade |
152 to 157 |
| 4 |
Appearance of solution |
Solution is clear |
| 5 |
UV absorbance |
NMT 0.1Ab |
| 6 |
Omeprazole impurity - C
[5-methoxy-2-[ [(4- methoxy -3,5-dimethyl pyridin -2-yl) methyl] thio]-1H- Benzimidazole] |
Any spot in chromatogram obtained with test solution (a) with a higher Rf value than that of the spot corresponding to omeprazole is not more intense than the spot in the chromatogram obtained with reference solution (b) (0.1%) |
| 7 |
Heavy metals |
Not more than 20 ppm |
| 8 |
Related substances |
The area of any peak, apart from the principle peak, in the chromatogram obtained with the test solution is not greater than the area of the peak in the chromatogram obtained with reference solution (b) (0.1%) |
| 9 |
Residual solvent |
|
a) Methylene
chloride |
NMT 100 ppm |
|
b) Chloroform |
NMT 50 ppm |
|
c) Trichloro ethylene |
NMT 100 ppm |
| 10 |
Residue on ignition |
NMT 0.1% |
| 11 |
Loss on drying |
NMT 0.2% |
| 12 |
Assay(% by mass) |
Omeprazole contains not less than 99.0% and not more than 101.0% on dried basis |
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