Description

Esomeprazole Magnesium Trihydrate is the S-isomer of omeprazole magnesium, a proton pump inhibitor (PPI) used to suppress gastric acid secretion. This high-purity active pharmaceutical ingredient (API) is critical for the formulation of effective and stable gastroesophageal reflux disease (GERD) treatments. It is primarily required by pharmaceutical manufacturers for the production of delayed-release tablets and capsules, serving the global healthcare market.

Application

• Pharmaceutical API: Primary active ingredient in prescription medications for acid-related disorders.
• GERD Treatment: Formulation of delayed-release tablets and capsules for 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 therapies for this hypersecretory condition.
• Helicobacter pylori Eradication: Used in combination therapy regimens for H. pylori infection.
• Generic Drug Manufacturing: Sourcing for the production of bioequivalent generic versions of branded esomeprazole products.

Basic Information

Product Name	Esomeprazole Magnesium Trihydrate
CAS No.	217087-09-7
Molecular Formula	C34H36MgN6O6S2 • 3H2O
Molecular Weight	767.15 g/mol (as trihydrate)
Synonyms	Esomeprazole Mg Trihydrate; (S)-Omeprazole Magnesium Trihydrate; Nexium® API; Perprazole Magnesium Trihydrate; Esomeprazole Magnesium Salt Trihydrate; 5-Methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Magnesium Salt Trihydrate; Magnesium bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-1H-1,3-benzodiazol-1-ide) trihydrate
EINECS	Contact for details

Quality Control

Our Esomeprazole Magnesium Trihydrate is manufactured under strict quality systems. It is typically tested to meet or exceed relevant pharmacopeial standards such as USP and EP monographs. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, ensuring compliance for pharmaceutical use.

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 maintain stability and potency.

Specification

Item	Specification
Appearance	White or almost white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (on anhydrous basis)	98.0% - 102.0%
Water Content (KF)	6.0% - 8.0%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	NMT 20 ppm

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