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Famotidine API
Famotidine is a potent histamine $H_2$-receptor antagonist used primarily to inhibit gastric acid secretion.
Famotidine API – Pharmaceutical Grade | Manufacturer & Exporter from India
Famotidine is a potent histamine $H_2$-receptor antagonist used primarily to inhibit gastric acid secretion. As a leading Famotidine Manufacturer, Shabbir Chemicals provides high-purity API to global pharmaceutical formulation plants, ensuring the highest standards of safety and efficacy for gastrointestinal treatments.
Product Overview
- Synonyms: 3-[({2-[(diaminomethylidene)amino]-1,3-thiazol-4-yl}methyl)sulfanyl]-N'-sulfamoylpropanimidamide
- CAS No: 76824-35-6
- Code: FAM-API
- Grade: USP / BP / EP / IP
- Mol. Formula: : $C_8H_{15}N_7O_2S_3$
- Mol. Weight: 337.45 g/mol
- Purity (Assay): 98.5% – 101.0% (on dried basis)
Description
Famotidine is a white to pale yellowish-white crystalline powder. It is an $H_2$ blocker that works by decreasing the amount of acid produced in the stomach. Unlike earlier $H_2$ antagonists, Famotidine is highly selective and does not interfere with the metabolism of other drugs by the hepatic cytochrome P450 enzyme system, making it a preferred choice for multi-drug therapeutic regimens.
Applications
- Peptic Ulcer Disease: Treatment and prevention of duodenal and gastric ulcers.
- GERD: Management of Gastroesophageal Reflux Disease (acid reflux).
- Zollinger-Ellison Syndrome: Treatment of pathological hypersecretory conditions.
- OTC Formulations: Active ingredient in over-the-counter antacids for heartburn and acid indigestion.
Technical Specifications
| Test Item | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Freely soluble in dimethylformamide; very slightly soluble in water |
| Melting Point | 160°C to 165°C |
| Loss on Drying | Not more than 0.5% |
| Residue on Ignition | Not more than 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Test Item | Specification |
| Individual Impurity | Not more than 0.3% |
| Total Impurities | Not more than 1.0% |
Safety & Hazard Information
- Signal Word: Warning
- Hazard Statements: * H315: Causes skin irritation.
- H319: Causes serious eye irritation.
- Precautionary Statements:
- P280: Wear protective gloves/protective clothing/eye protection/face protection.
- P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes.
- Handling: Use in a well-ventilated area. Avoid dust formation and inhalation.
Packaging & Logistics
- Standard Packaging: 25 kg Fiber Drums with double polyethylene liners.
- Storage: Store in a well-closed, light-resistant container at controlled room temperature.
- Export Markets: Major exporter to North America, Europe, MENA region, and South East Asia.
- Documentation: Certificate of Analysis (COA), Method of Analysis (MOA), and Drug Master File (DMF) available.
Why Source from Us?
Our Fluconazole API is manufactured in a state-of-the-art facility that adheres strictly to cGMP guidelines. We prioritize particle size consistency and impurity profiling to ensure our clients receive a product that is easy to formulate into tablets, capsules, or intravenous infusions.