Lansoprazole is a strategic Active Pharmaceutical Ingredient (API) belonging to the proton pump inhibitor (PPI) class, manufactured at Parand Darou Co. in strict compliance with international pharmacopoeial requirements (BP and USP). This API, through targeted and potent suppression of gastric acid secretion, serves as a key raw material for formulating final pharmaceutical products—such as enteric-coated pellets in capsules and orally disintegrating tablets. It is indicated for the treatment of peptic ulcers, gastroesophageal reflux disease (GERD), erosive esophagitis, Zollinger-Ellison syndrome, and as a component in combination regimens for H. pylori eradication.
Mechanism of Action & Clinical Utility
Lansoprazole is a lipophilic, weak base prodrug that, upon absorption and distribution, enters the highly acidic environment of the secretory canaliculi of gastric parietal cells. In this acidic environment, lansoprazole is protonated and converted into its active sulfonamide form. This active metabolite forms an irreversible covalent disulfide bond with the cysteine residues of the H+/K+-ATPase enzyme (the hydrogen-potassium pump), effectively halting the final stage of hydrochloric acid production. Its inhibitory effect is dose-dependent, significantly suppressing both basal and stimulated gastric acid secretion.
Quality Standards & Storage Requirements
The Lansoprazole API synthesized in Parand Darou’s production lines exhibits a chemical purity of at least 99.4%, with an assay value strictly within the range of 99.0% to 101.0% (calculated on an anhydrous basis). Given the sensitivity of the benzimidazole structure to moisture and light, the water content is controlled below 0.1%, ensuring chemical stability for at least 2 years at ambient room temperature. This product must be stored in airtight containers and protected from direct light to maintain its integrity.
General Information
| Product Name | Lansoprazole | |
| Chemical Name | 2-[(RS)-[[3-Methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl]sulfinyl]-1H-benzimidazole | |
| Manufacturer | Parand Darou Co. | |
| CAS No. | 103577-45-3 | |
| Category | Proton pump inhibitor | |
| Pharmacopoeia | BP, USP |
Specification
| Molecular formula | C16H14F3N3O2S | Sulfated ash | Max. 0.1% | |||
| Molecular weight | 369.4 | Purity | Min. 99.4% | |||
| Appearance | White/brownish powder | Assay | 99.0% – 101.0% (anhydrous) | |||
| Solubility | Practically insoluble in water | Storage | Airtight, light-protected | |||
| Water | Max. 0.1% | Stability | 2 years at R.T |
