CAS number: 217087-09-7
Molecular formula: C34H42MgN6O9S2
molecular weight: 767.2
Chemical structure:
SR. NO | TEST | SPECIFICATION | RESULTS | ||
1. | Description | White to slightly coloured powder | Off white color powder | ||
2. | Solubility | Soluble in methanol; slightly soluble in water, practically insoluble in heptane. | Complies | ||
3. | Identification | ||||
a) By IR | IR spectrum of test sample should concordant wit IR spectrum of working standard. | Complies | |||
b) By AAS | The sample solution, prepared and tested as directed in the test for content of Magnesium, exhibits a significant absorption at 285.2 nm. | Complies | |||
4. | Content of Magnesium | Should be between 3.30% and 3.55% (On anhydrous basis). | Complies | ||
5. | Colour of solution | The absorbance of the solution at 440 nm, in 1-cm cells, should not be more than 0.2 Abs. | Complies | ||
6. | Water content | Should be between 6.0% w/w and 8.0% w/w | 6.9% | ||
7. | Related substances by HPLC | ||||
Omeprazole N-Oxide | Not more than 0.1% | Not detected | |||
Omeprazole Sulfone | Not more than 0.2% | Not detected | |||
Any other individual impurities | Not more than 0.1% | 0.02% | |||
Total impurities | Not more than 0.5% | 0.08% | |||
8. | Enantiomeric purity | NMT 0.2 % of the R-enantiomer. | 0.10% | ||
9. | Asaay by HPLC | Not Less than 98.0% w/w and Not more than 102.0% w/w | 99.3% W/W |