Description

Lansoprazole (Sodium) is the sodium salt form of the proton pump inhibitor lansoprazole, a key active pharmaceutical ingredient (API) used to suppress gastric acid secretion. This compound is critical for ensuring the stability, bioavailability, and manufacturability of finished pharmaceutical dosage forms. It is primarily required by pharmaceutical manufacturers and research institutions developing and producing treatments for acid-related gastrointestinal disorders such as gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription and over-the-counter (OTC) medications for acid suppression.
• Oral Solid Dosage Forms: Formulation into delayed-release capsules, tablets, and orally disintegrating tablets (ODTs).
• Drug Product Development: Serves as a reference standard and starting material in R&D for new formulations and generic drug development.
• Combination Therapies: Used in fixed-dose combination products with antibiotics for Helicobacter pylori eradication regimens.
• Clinical Research: Utilized in bioavailability, bioequivalence, and pharmacokinetic studies.
• Veterinary Pharmaceuticals: Potential application in veterinary medicine for treating acid-related conditions in animals.

Basic Information

Product Name	Lansoprazole (Sodium)
CAS No.	226904-00-3
Molecular Formula	C16H13F3N3NaO2S
Molecular Weight	389.34 g/mol
Synonyms	Lansoprazole Sodium; Lansoprazole Sodium Salt; AG-1749 Sodium Salt; (RS)-Lansoprazole Sodium; 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]-1H-benzimidazole Sodium Salt; Prevacid® (Brand Name Reference); Lanzor® (Brand Name Reference); Zoton® (Brand Name Reference)
EINECS	Contact for details

Quality Control

Our Lansoprazole (Sodium) is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with major pharmacopeial standards such as USP and EP. A detailed Certificate of Analysis (COA) documenting all test results is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to slightly yellowish powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.