Omeprazole is a critical and widely utilized Active Pharmaceutical Ingredient (API) belonging to the proton pump inhibitor (PPI) class, synthesized at Parand Darou Co. with the highest purity levels and strict adherence to pharmacopoeial compliance. As a first-line therapeutic agent, it serves as a fundamental raw material in the formulation of various final dosage forms—such as pellet-filled capsules, enteric-coated tablets, and oral suspensions. It is indicated for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, and as an essential component in combination regimens for H. pylori eradication.
Mechanism of Action & Clinical Features
Omeprazole acts as a weak base prodrug. Upon reaching the highly acidic environment of the gastric parietal cell secretory canaliculi, it is converted into its active sulfonamide form. This active metabolite binds covalently to the sulfhydryl groups of the H+/K+-ATPase enzyme (hydrogen-potassium pump), selectively and irreversibly inhibiting the final step of hydrochloric acid production and secretion. Omeprazole’s inhibitory effect is independent of the acid secretion stimulus (whether acetylcholine, gastrin, or histamine), thereby exerting stable and effective control over gastric pH.
Quality, Standards & Storage Requirements
The Omeprazole API produced at Parand Darou complies with international quality requirements set forth by BP and USP. Key quality attributes include a chemical purity of at least 99.5%, precise control of specific Impurities F and G (max. 350 ppm total), extremely low moisture content (max. 0.2%), and a sulfated ash content not exceeding 0.1%. Due to the sensitivity of its benzimidazole structure to heat, moisture, and light, this product must be stored in airtight, light-protected containers at refrigerated temperatures (2°C to 8°C) to maintain stability.
General Information
| Product Name | Omeprazole | |
| Chemical Name | 5-Methoxy-2-[(RS)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-1H-benzimidazole | |
| Manufacturer | Parand Darou Co. | |
| CAS No. | 73590-58-6 | |
| Category | Proton pump inhibitor | |
| Pharmacopoeia | BP, USP |
Specification
| Molecular formula | C17H19N3O3S | Sulfated ash | Max. 0.1% | |||
| Molecular weight | 345.42 | Purity | Min. 99.5% | |||
| Appearance | White/off-white powder | Assay | 99.0% – 101.0% (dried) | |||
| Solubility | Sparingly sol. in ethanol/methanol; sol. in DCM; insol. in water. | Storage | Airtight, 2-8°C | |||
| Water | Max. 0.2% | Stability | 2 years | |||
| Impurity F&G | Max. 350 ppm |
