Description

Esomeprazole Magnesium Dihydrate is the magnesium salt dihydrate form of the S-isomer of omeprazole, a proton pump inhibitor. It is a key active pharmaceutical ingredient (API) valued for its superior bioavailability and stability profile compared to the racemic mixture. This high-purity compound is essential for pharmaceutical manufacturers developing and producing advanced gastroesophageal reflux disease (GERD) and peptic ulcer medications. Its consistent quality ensures reliable performance in final dosage forms such as delayed-release tablets and capsules.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for acid-related disorders.
• GERD Treatment: Formulation into delayed-release tablets and capsules for treating gastroesophageal reflux disease.
• Peptic Ulcer Therapy: Used in medications for the healing and prevention of gastric and duodenal ulcers.
• Zollinger-Ellison Syndrome: A critical component in formulations for managing gastric acid hypersecretion.
• Helicobacter pylori Eradication: Used in combination therapy regimens (e.g., with antibiotics) for H. pylori infection.
• Drug Development: Serves as a reference standard and building block in pharmaceutical R&D for new gastroprotective agents.
• Generic Drug Manufacturing: A vital raw material for producing bioequivalent generic versions of branded esomeprazole products.

Basic Information

Product Name	Esomeprazole Magnesium Dihydrate
CAS No.	217087-10-0
Molecular Formula	C34H36MgN6O6S2 • 2H2O
Molecular Weight	713.12 g/mol (as dihydrate)
Synonyms	Esomeprazole Magnesium Trihydrate (common alias); (S)-Omeprazole Magnesium Salt Dihydrate; Nexium® API; Magnesium bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-1H-benzimidazol-1-ide) dihydrate; Esomeprazole Mg; (-)-Omeprazole Magnesium Salt; Perprazole Magnesium; JH-IX-119-1
EINECS	Contact for details

Quality Control

Our Esomeprazole Magnesium Dihydrate is manufactured under strict quality systems. It undergoes rigorous analytical testing to ensure compliance with major pharmacopeial standards such as USP and EP. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We are committed to supplying material that meets the stringent requirements for GMP pharmaceutical manufacturing.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. The original container should be kept sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	4.5% - 6.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbial Limits	Complies with EP/USP

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