Description

Esomeprazole Sodium CAS NO 161796-78-7 is the sodium salt form of esomeprazole, the (S)-isomer of omeprazole, and a potent proton pump inhibitor (PPI). It is a critical active pharmaceutical ingredient (API) valued for its superior bioavailability and metabolic profile compared to racemic mixtures. This compound is essential for pharmaceutical manufacturers developing and producing advanced gastroesophageal reflux disease (GERD) and peptic ulcer treatments, including delayed-release tablets, capsules, and injectable formulations.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for acid-related disorders.
• GERD Treatment Formulations: Manufacture of delayed-release oral dosage forms (tablets, capsules) for gastroesophageal reflux disease.
• Peptic Ulcer Therapy: Key component in drugs for the healing and prevention of gastric and duodenal ulcers.
• Zollinger-Ellison Syndrome Management: Used in formulations for the treatment of pathological hypersecretory conditions.
• Helicobacter pylori Eradication: Incorporated into combination therapy regimens alongside antibiotics.
• Injectable Drug Products: Serves as the API for sterile preparations where oral administration is not feasible.
• Pharmaceutical Research & Development: Used as a reference standard and in the development of new drug delivery systems.
• Generic Drug Manufacturing: Sourcing for the production of bioequivalent generic versions of branded PPI medications.

Basic Information

Product Name	Esomeprazole Sodium
CAS No.	161796-78-7
Molecular Formula	C17H18N3NaO3S
Molecular Weight	367.40 g/mol
Synonyms	(S)-Omeprazole Sodium Salt; Esomeprazole Na; Sodium (S)-5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1H-benzimidazol-1-ide; Nexium® API Sodium Salt; Perprazole Sodium; H 199/18 Sodium Salt; E 3810 Sodium Salt
EINECS	Contact for details

Quality Control

Our Esomeprazole Sodium is manufactured under strict quality systems in compliance with current Good Manufacturing Practices (cGMP). Each batch undergoes comprehensive analytical testing, including HPLC for assay and impurity profiling, to meet stringent pharmacopeial standards such as USP and EP. A Certificate of Analysis (COA) detailing purity, related substances, residual solvents, and other critical parameters is provided with every shipment to ensure full traceability and regulatory compliance for our global pharmaceutical partners.

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 product is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity to prevent degradation and maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Conforms to standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Water Content (KF)	≤ 5.0%
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.