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Omeprazole
Omeprazole is a world-class substituted benzimidazole and the first of the Proton Pump Inhibitors (PPIs).
Omeprazole API – Proton Pump Inhibitor (PPI) | Manufacturer & Exporter from India
Omeprazole is a world-class substituted benzimidazole and the first of the Proton Pump Inhibitors (PPIs). As a specialized Omeprazole Manufacturer, Shabbir Chemicals offers high-purity API and Pellets (8.5% to 22.5%) for global distribution. It is the gold standard for treating acid-related gastrointestinal disorders by inhibiting the $H^+/K^+$-ATPase enzyme system in gastric parietal cells.
Product Overview
- Synonyms: 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-1H-benzimidazole
- CAS No: 73590-58-6
- Code: OME-API
- Grade: USP / BP / EP / IP
- Mol. Formula: : $C_{17}H_{19}N_3O_3S$
- Mol. Weight: 345.42 g/mol
- Purity (Assay): 99.0% – 101.0% (on anhydrous basis)
Description
Omeprazole is a white to off-white crystalline powder that is photosensitive and moisture-sensitive. Unlike $H_2$-receptor antagonists, Omeprazole acts on the final stage of gastric acid secretion by irreversibly blocking the “proton pump.” Its highly effective acid-suppression profile makes it a primary choice for both short-term relief and long-term management of hypersecretory conditions.
Applications
- Gastric & Duodenal Ulcers: Short-term treatment of active benign ulcers.
- GERD: Management of Gastroesophageal Reflux Disease and erosive esophagitis.
- Zollinger-Ellison Syndrome: Treatment of pathological hypersecretory conditions.
- H. pylori Eradication: Used in combination with antibiotics (Amoxicillin/Clarithromycin) for triple therapy.
- OTC Formulations: Widely used in 20mg delayed-release tablets and capsules for frequent heartburn.
Technical Specifications
| Test Item | Specification |
|---|---|
| Appearance | White or almost white crystalline powder |
| Solubility |
Soluble in Methanol/DCM; slightly soluble in Ethanol; Insoluble in water |
| Identification | By IR Spectrum / HPLC retention time |
| Melting Point | 155°C to 160°C (with decomposition) |
| Loss on Drying | Not more than 0.5% |
| Residue on Ignition | Not more than 0.1% |
| Heavy Metals | ≤ 20 ppm |
| Total Impurities | Not more than 0.5% |
Safety & Hazard Information
- Signal Word: Warning
- Hazard Statements: * H315: Causes skin irritation.
- H317: May cause an allergic skin reaction.
- H319: Causes serious eye irritation.
- Precautionary Statements:
- P261: Avoid breathing dust/fumes.
- P280: Wear protective gloves and eye protection.
- P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes.
- Storage Requirement: Sensitive to heat and light. Must be stored in airtight containers, protected from light, at temperatures between 2°C to 8°C (for long-term stability).
Packaging & Logistics
- Standard Packaging: 25 kg HDPE Drums with inner double black LDPE bags (to prevent light degradation).
- Forms Available: Powder (API), Enteric Coated Pellets (7.5%, 8.5%, 10%, 20%, 22.5%).
- Export Markets: Trusted supplier to pharmaceutical hubs in Europe, SE Asia, and Latin America.
- Documentation: USP/BP compliant COA, Stability Data, and GMP certification.
Why Source From Shabbir Chemicals?
Our Omeprazole API is produced using advanced synthesis routes that minimize related substances (Impurity A & D). We provide customized particle sizes and pellet concentrations to meet the specific formulation requirements of our clients, ensuring optimal bioavailability and enteric-release profiles.