Description

Esomeprazole Magnesium Hydrate is the magnesium salt form of the S-isomer of omeprazole, a proton pump inhibitor (PPI). This high-purity active pharmaceutical ingredient (API) is critical for the formulation of effective and stable gastroesophageal reflux disease (GERD) and peptic ulcer treatments. It is primarily utilized by pharmaceutical manufacturers in the production of delayed-release tablets and capsules, offering superior acid control and stability profiles.

Application

• Pharmaceutical API: Core active ingredient in prescription and generic medications for acid-related disorders.
• GERD Treatment: Formulation of delayed-release tablets and capsules to treat gastroesophageal reflux disease.
• Peptic Ulcer Therapy: Used in medications for the healing and prevention of gastric and duodenal ulcers.
• Zollinger-Ellison Syndrome Management: A key component in formulations for this hypersecretory condition.
• Erosive Esophagitis Healing: Incorporated into drugs aimed at healing damage to the esophagus from stomach acid.
• Combination Therapies: Serves as the PPI component in combination drug products, such as those with antibiotics for H. pylori eradication.
• Drug Intermediate: Used in the synthesis of more complex pharmaceutical compounds.
• Research & Development: Serves as a reference standard and raw material in pharmaceutical R&D laboratories.

Basic Information

Product Name	Esomeprazole Magnesium Hydrate
CAS No.	668985-31-7
Molecular Formula	C34H36MgN6O6S2 · xH2O
Molecular Weight	713.12 (anhydrous basis)
Synonyms	Esomeprazole Magnesium Trihydrate; (S)-Omeprazole Magnesium; Nexium® API; Esomeprazole Mg; Magnesium bis[(S)-5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1H-benzimidazol-1-ide]; 1H-Benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-, magnesium salt (2:1), (S)-; Perprazole Magnesium
EINECS	Contact for details

Quality Control

Our Esomeprazole Magnesium Hydrate is manufactured under strict quality management systems. It is tested to meet or exceed relevant pharmacopeial standards, including USP and EP monographs, ensuring identity, purity, strength, and composition. Comprehensive testing includes assay, related substances, residual solvents, and specific tests for enantiomeric purity. A Certificate of Analysis (COA) is provided with each batch to guarantee consistent quality and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity to prevent degradation.

Specification

Item	Specification
Appearance	White or almost white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (on anhydrous basis)	98.0% - 102.0%
Related Substances (HPLC)	Individual impurity: NMT 0.15% Total impurities: NMT 0.5%
Enantiomeric Purity (HPLC)	NLT 99.5% (S-isomer)
Water Content (KF)	7.0% - 9.0% (Trihydrate)
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	NMT 20 ppm
Sulfated Ash	NMT 0.1%

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