Omeprazole is a proton pump inhibitor that has a strong and long-lasting inhibitory effect on gastric acid secretion in animals and humans. Clinically, it is used to treat peptic ulcers, reflux esophagitis, Zollinger-Ellison syndrome, and eradicate Helicobacter pylori (HP).
Omeprazole is a proton pump inhibitor that has a strong and long-lasting inhibitory effect on gastric acid secretion in animals and humans. Clinically, it is used to treat peptic ulcers, reflux esophagitis, Zollinger-Ellison syndrome, and eradicate Helicobacter pylori (HP).
| Chemical Name | 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole |
| CAS Number | 73590-58-6 |
| Molecular Formula | C17H19N3O3S |
| Molecular Weight | 345.42 |
| Molecular Structure |  |
| Packing | Complies |
| Capacity | Complies |
| Storage | 2-8°C |
| Application | Omeprazole is a proton pump inhibitor that has a strong and long-lasting inhibitory effect on gastric acid secretion in animals and humans. Clinically, it is used to treat peptic ulcers, reflux esophagitis, Zollinger-Ellison syndrome, and eradicate Helicobacter pylori (HP). |
| Items | Specifications |
|---|---|
| Appearance | White or almost white powder |
| Appearance of solution | Solution S is clear |
| Identification | Meet the requirements |
| Impurities F and G | The solution determined at 440 nm is not greater than 0.10 |
| Loss on Drying | ≤0.2% |
| Sulfated Ash | ≤0.1% |
| Residue of Solvents - Triethylamine | ≤100ppm |
| Residue of Solvents - Acetone | ≤5000ppm |
| Related Substances - Impurity D | ≤0.15% |
| Related Substances - Impurity E | ≤0.15% |
| Related Substances - Unspecified Impurities | ≤0.10% |
| Related Substances - Total Impurities | ≤0.5% |
| Chromatographic Purity by HPLC - Benzimidazole | ≤0.15% |
| Chromatographic Purity by HPLC - Omeprazole Related Compound E | ≤0.15% |
| Chromatographic Purity by HPLC - Omeprazole Related Compound I | ≤0.15% |
| Chromatographic Purity by HPLC - Desmethoxy Omeprazole | ≤0.15% |
| Chromatographic Purity by HPLC - Omeprazole Related Compound A | ≤0.15% |
| Chromatographic Purity by HPLC - Omeprazole 4-chloroanalog | ≤0.15% |
| Chromatographic Purity by HPLC - Ufiprazole | ≤0.15% |
| Chromatographic Purity by HPLC - Any Other Individual Impurity | ≤0.10% |
| Chromatographic Purity by HPLC - Total Impurities | ≤1.0% |
| Particle Distribution - Mean diameter D(4,3) | 2-12μm |
| Particle Distribution - Upper limit not less than 90% | <28μm |
| Particle Distribution - Lower limit not more than 15% | <1μm |
| Titration Assay | 99.0% to 101.0% on dry basis |
| HPLC Assay | 98.0% to 102.0% on dry basis |
| Standard | EP |
* The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The users are suggested to select the suitability of the products and methods of application.
Used in the production of tablets, capsules, and oral solutions.
Suitable for processing into sterile injectable formulations.
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