Description

Omeprazole Sodium is the sodium salt form of the widely used proton pump inhibitor, omeprazole. This active pharmaceutical ingredient (API) is critical for the formulation of stable and effective anti-ulcer and anti-acid medications. It is primarily required by pharmaceutical manufacturers for the production of injectable solutions and other dosage forms where enhanced solubility and bioavailability are essential. The compound is supplied to meet the stringent quality standards demanded by the global pharmaceutical industry.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of finished dosage forms for the treatment of gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome.
• Injectable Formulations: Key component in sterile injectable products, leveraging its sodium salt form for improved solubility and stability in aqueous solutions.
• Oral Solid Dosages: Used in the production of enteric-coated tablets, delayed-release capsules, and other oral medications designed for targeted release in the small intestine.
• Research & Development: Serves as a critical reference standard and starting material in pharmaceutical R&D for developing new acid-suppression therapies and generic drugs.
• Veterinary Medicine: Applicable in veterinary pharmaceutical products for the management of gastric acid-related disorders in animals.

Basic Information

Product Name	Omeprazole Sodium
CAS No.	95510-70-6
Molecular Formula	C17H18N3NaO3S
Molecular Weight	367.40 g/mol
Synonyms	5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Sodium Salt; Sodium Omeprazole; Omeprazole Sodium Salt; Omeprazole Na; LOSEC; Prilosec (referring to the drug product); (RS)-Omeprazole Sodium; Gastrazole Sodium
EINECS	Contact for details

Quality Control

Our Omeprazole Sodium is manufactured under strict quality management systems. Each batch is tested to ensure compliance with major pharmacopoeial standards such as USP, EP, and JP. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing parameters including assay, purity, related substances, residual solvents, and microbiological quality. We support audits and provide full traceability documentation.

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 off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms to reference standard
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
Microbiological Enumeration	Complies with EP/ USP
pH (1% Solution)	9.0 - 11.0

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