Pantoprazole Sodium is a highly effective Active Pharmaceutical Ingredient (API) belonging to the proton pump inhibitor (PPI) therapeutic class, manufactured at Parand Darou Co. under strict international quality standards. As an advanced-generation gastric acid secretion inhibitor, it serves as an essential raw material in the commercial production of finished dosage forms—including delayed-release tablets, capsules, and lyophilized parenteral formulations. It is widely indicated for the treatment of gastric and duodenal ulcers, gastroesophageal reflux disease (GERD), pathological hypersecretory conditions such as Zollinger-Ellison syndrome, and as a core agent in combination eradication protocols for Helicobacter pylori.
Mechanism of Action & Clinical Advantages
Pantoprazole sodium acts through selective, irreversible inhibition of the H+/K+-ATPase enzyme system (the gastric proton pump) located at the secretory surface of gastric parietal cells, effectively blocking the final step of hydrochloric acid production. Clinically, Pantoprazole offers distinct therapeutic advantages over earlier PPIs, including minimal risk of drug-drug interactions due to its lower affinity for the hepatic CYP2C19 isoenzyme system, superior chemical stability at neutral to mildly acidic pH levels, and proven safety profiles in long-term maintenance therapy. Its sesquihydrate crystal lattice configuration provides optimal solid-state stability.
Quality Standards, Specifications & Storage
Synthesized in full compliance with the rigorous monographs of the British Pharmacopoeia (BP) and the United States Pharmacopeia (USP), Pantoprazole Sodium API produced by Parand Darou exhibits high chromatographic purity (minimum 99.5%), tightly regulated moisture content (sesquihydrate balance of 5.9% to 6.9%), and a verified specific optical rotation (-0.4° to +0.4°). Given the sensitivity of substituted benzimidazoles to photolytic exposure, the product must be preserved in tight, light-resistant containers. Under recommended controlled room temperature storage, it demonstrates guaranteed chemical and physical stability for at least 24 months.
General Information
| Product Name | Pantoprazole Sodium | |
| Chemical Name | Sodium 5-(difluoromethoxy)-2-[(RS)-[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]benzimidazol-1-ide sesquihydrate | |
| Manufacturer | Parand Darou Co. | |
| CAS No. | 164579-32-2 | |
| Category | Proton pump inhibitor | |
| Pharmacopoeia | BP, USP |
Specification
| Molecular formula | C16H14F2N3NaO4S · 1½ H2O | Optical rotation | -0.4° to +0.4° | |||
| Molecular weight | 432.37 | Purity | Min. 99.5% | |||
| Appearance | White or almost white powder | Assay | 99.0% to 101.0% (anhydrous) | |||
| Solubility | Freely sol. in water & ethanol (96%); practically insol. in hexane | Storage | Protected from light, tight container | |||
| Water | 5.9% to 6.9% | Stability | Stable at least 2 years at R.T. |
