Esomeprazole Cas 119141-88-7
Specification
Items | Specifications | Results |
Appearance | White to off white spherical pellets | Meets the requirement |
Solubility | Sparingly soluble in water and in acetone,freely soluble in Methanol,Ethanol(96%);practically insoluble in 1 mol/L sodium hydroxide. | Conforms |
Identification (by HPLC) | Acceptance criteria:(0.98-1.02) | 1.00 |
Bulk Density | Between 0.70 to 0.90 g/ml | 0.83g/ml |
Moisture Content | NMT 5.00%w/w(by KF) | 2.27% |
Dissolution in phosphate buffer Ph6.8 | Not less than 80.0% after 30minutes | 97.0% |
Assay of Esomeprazole | 20.25%-24.75%w/w | 22.48%w/w |
Chromatographic purity(HPLC) |
|
|
Omeprazole sulphone | NMT 0.50% | 0.012% |
Any impurity | NMT 0.20% | 0.033% |
Total impurities | NMT 2.00% | 0.18% |
Size of Pellets | Not less than 90% should pass through 20 ASTM; Not more than 10% should pass through 25 ASTM. | 91.17% 5.81% |
Conclusion | The product conforms to the above specifications. |
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Esomeprazole is a medication primarily used to treat conditions related to excess stomach acid. It belongs to a class of drugs called proton pump inhibitors (PPIs).
What it is and How it Works:
Mechanism: It works by binding to and inhibiting the "proton pump" (H+/K+ ATPase) in the stomach's acid-producing cells. This action significantly reduces the production of stomach acid.
Chemical Nature: It is the S-isomer of omeprazole (the active ingredient in Prilosec). Think of it as a refined, more potent version that is metabolized more slowly by the body, leading to potentially better acid control for some people.
What it is Useful For (Medical Uses):
Esomeprazole is prescribed for both short-term relief and long-term management of acid-related conditions:
Gastroesophageal Reflux Disease (GERD):
Heartburn & Acid Reflux: Heals irritation of the esophagus and provides relief from the burning sensation caused by stomach acid backing up.
Erosive Esophagitis: Helps heal and prevent damage to the esophagus lining.
Peptic Ulcer Disease:
Stomach and Duodenal Ulcers: Promotes healing of ulcers caused by stomach acid.
Helicobacter pylori Eradication: Used in combination with antibiotics to kill the H. pylori bacteria, a common cause of ulcers.
Zollinger-Ellison Syndrome: A rare condition where the stomach produces excessive acid.
Prevention of NSAID-Induced Ulcers: For patients who need long-term pain relievers like ibuprofen or aspirin, which can irritate the stomach.
Other Uses: Sometimes used for severe indigestion (functional dyspepsia) or to reduce the risk of bleeding from ulcers in critically ill patients.
Common Brand Names:
Important Considerations and Warnings:
Not for Immediate Relief: It is not an antacid. It can take 1-4 days to feel its full effect, as it works by preventing acid production, not neutralizing existing acid.
Administration: Should be taken on an empty stomach, usually 30-60 minutes before the first meal of the day. The capsule/tablet should be swallowed whole, not crushed or chewed.
Potential Side Effects: Generally well-tolerated, but can include headache, nausea, diarrhea, abdominal pain, gas, and constipation.
Serious Risks (with long-term/high-dose use):
Increased risk of fractures (hip, wrist, spine).
Vitamin B12 and magnesium deficiency.
Increased risk of certain infections like C. difficile diarrhea and pneumonia.
Possible kidney problems.
Rebound Acid Hypersecretion: Stopping the drug abruptly after long-term use can cause a temporary surge in acid production. It's best to taper off under a doctor's guidance.
Drug Interactions: Can interfere with the absorption of certain drugs (e.g., clopidogrel, HIV medications, some antifungals). Always inform your doctor of all medications you are taking.
Summary:
Esomeprazole is a highly effective and widely used PPI that reduces stomach acid production. It is extremely useful for healing and managing conditions like GERD, ulcers, and esophagitis. However, it should be used at the lowest effective dose for the shortest duration necessary due to potential risks associated with long-term use. Always consult a doctor or pharmacist for proper diagnosis, dosage, and to discuss if it's the right medication for you.
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Spring Zhang
Email: export@fortunachem.com
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Tel: +86-27-59207892
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