| Function: | Visceral System Medication |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
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| Omeprazole sodium | EP | |
| Characters | White, off-white or white-creamish spherical microganules, regular and without detectable defects. | |
| Identify(by HPLC) | The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard solution, as obtained in the assay | |
| Water | ≤ 1.5% | |
| Gastro resistance | Not less than 85% of labeled amount of Omeprazole should retain in 0.1N HCl after 2 hours | |
| Dissolution buffer | Not less than 75% of labeled amount of Omeprazole should dissolve in Phosphate buffer pH 6.8 in 30 minutes | |
| Related substances | Total impurities | ≤ 0.5% |
| Individual impurities | ≤ 2.0% | |
| Residual solvents | a) Acetone | ≤ 3000ppm |
| b)Methylene chloride | ≤ 600ppm | |
| c)Methanol | ≤ 3000ppm | |
| d)Toluene | ≤ 890ppm | |
| Assay(HPLC) | 8.0-9.0 % | |
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