Description

Omeprazole Magnesium is the magnesium salt form of the widely used proton pump inhibitor, omeprazole, offering enhanced stability and handling properties. This active pharmaceutical ingredient (API) is critical for the formulation of delayed-release oral solid dosage forms designed to effectively reduce gastric acid production. It is an essential raw material for pharmaceutical manufacturers developing treatments for acid-related disorders such as gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Global procurement teams seek a reliable supply of high-purity Omeprazole Magnesium CAS NO 95382-33-5 to ensure consistent drug efficacy and meet stringent regulatory standards.

Application

• Pharmaceutical API: Primary use as the active ingredient in delayed-release capsules and tablets for acid suppression therapy.
• Generic Drug Manufacturing: Sourcing for cost-effective production of generic omeprazole formulations following patent expirations.
• Combination Therapies: Used in fixed-dose combination products alongside other APIs, such as antibiotics for H. pylori eradication.
• Clinical Trial Materials: Supply of GMP-grade material for bioavailability studies and new formulation development.
• Veterinary Pharmaceuticals: Formulation into medications for treating gastric ulcers in animals, particularly in equine and companion animal care.
• Contract Manufacturing & Tolling: Bulk supply to CDMOs (Contract Development and Manufacturing Organizations) for finished dosage form production.

Basic Information

Product Name	Omeprazole Magnesium
CAS No.	95382-33-5
Molecular Formula	C34H36MgN6O6S2
Molecular Weight	713.12 g/mol
Synonyms	Omeprazole Magnesium Salt; Omeprazole Mg; 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Magnesium Salt; Losec Magnesium; Prilosec Magnesium; (RS)-Omeprazole Magnesium; Magnesium bis(5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methanesulfinyl]-1H-1,3-benzodiazole); H 168/68 Magnesium
EINECS	Contact for details

Quality Control

Our Omeprazole Magnesium is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards including USP, EP, and JP. Each batch undergoes rigorous analytical testing for identity, assay, related substances, residual solvents, and microbiological purity. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing all test results against agreed specifications. We support our partners' regulatory filings with full GMP and DMF documentation as required.

Storage

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

Specification

Item	Specification
Appearance	White or almost white powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference
Assay (on dried basis)	98.0% - 102.0%
Related Substances (HPLC)	Total impurities: NMT 1.0% Any individual impurity: NMT 0.5%
Loss on Drying	NMT 1.0%
Residue on Ignition (Sulfated Ash)	7.5% - 8.5%
Heavy Metals	NMT 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbiological Enumeration	Total aerobic microbial count: NMT 1000 cfu/g Total combined yeasts/molds: NMT 100 cfu/g

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