| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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Esomeprazole is the latest in the class of agents called the protonpump inhibitors(PPIs). These drugs inhibit gastric secretion by binding to hydrogen- potassium adenosinetriphosphatase (H+, K+-ATPase) in gastric parietal cells. The PPIs' ability to provide rapid symptomatic control and their demonstrated efficacy in healing erosive esophagitis have led them to be viewed as agents of choice for treating patients with gastric acid-related diseases, including gastroesophageal reflux disease(GERD), gastric ulcers, and duodenal ulcers. In addition, these agents have been shown to be effective in the treatment of Zollinger-Ellison syndrome and Barrett's esophagus. Esomeprazole is the fourth PPI to be approved for use in the United States, following omeprazole; the other available PPIs are lansoprazole, pantoprazole, and rabeprazole. PPIs have similar chemical structures and a shared mechanism of action. Esomeprazole, the S-isomer of omeprazole, is the first PPI developed as a single optical isomer. Esomeprazole has an improved pharmacokinetic profile over omeprazole (a racemic mixture of Sand Roptical isomers), resulting in more potent acid suppression.
| Item | Test Standard | Testing Result | |
| Assay | 99% | Complies | |
| Apperence | White Powder | Complies | |
| Particle Size | 100% pass 80 mesh | Complies | |
| Oder | Characteristic | Complies | |
| Taste | Characteristic | Complies | |
| Loss on Drying | ≤5.0% | 2.20% | |
| Residue on Ignition | ≤0.1% | 0.05% | |
| Residual | ≤0.1% | Complies | |
| Residual Ethanol | ≤0.5% | Complies | |
| Heave Mentals | ≤10ppm | Complies | |
| Na | ≤0.1% | <0.1% | |
| Pb | ≤3 ppm | Complies | |
| Total Plate | <1000CFU/g | Complies | |
| Yeast & Mold | <100 CFU /g | Complies | |
| E. Coli | Negative | Complies | |
| Salmonella | Negative | Complies | |
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