Description

Esomeprazole Magnesium Trihydrate USP

Esomeprazole Magnesium Trihydrate USP is a high-purity, pharmaceutical-grade proton pump inhibitor (PPI) used as an active pharmaceutical ingredient (API) in the treatment of acid-related gastrointestinal disorders, including gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. This salt form of the S-isomer of Omeprazole offers improved pharmacokinetics, enhanced bioavailability, and prolonged acid suppression. Esomeprazole Magnesium Trihydrate

• Is a USP-compliant magnesium salt of the S-isomer of Omeprazole
• Is used for treatment of GERD, erosive esophagitis, and acid hypersecretion syndromes
• Has superior bioavailability and longer duration of acid suppression compared to racemic omeprazole
• Is suitable for delayed-release capsules, tablets, and granule formulations
• Is manufactured under Good Manufacturing Practice (GMP) conditions
• Is supplied with complete regulatory documentation including Certificate of Analysis (CoA) and supporting technical data

Esomeprazole is a substituted Benzimidazole that suppresses gastric acid secretion by selectively inhibiting the H⁺/K⁺-ATPase enzyme in parietal cells. The magnesium salt trihydrate form enhances stability, solubility, and absorption in enteric-coated formulations.

In pharmaceutical formulations, Esomeprazole Magnesium Trihydrate USP is used in:

• Delayed-release oral dosage forms for once-daily treatment of acid reflux and GERD
• Helicobacter pylori eradication regimens in combination with antibiotics
• NSAID-associated ulcer prevention therapies
• Over-the-counter heartburn products in regulated strengths and dosages

Because Esomeprazole is acid-labile, it must be formulated with enteric protection to ensure delivery to the duodenum. The trihydrate form is compatible with coating technologies and controlled-release systems.

CarboMer supplies Esomeprazole Magnesium Trihydrate USP with stringent controls over enantiomeric purity, polymorphic form, particle size, and related substances. Each lot meets USP monograph requirements and is produced under GMP conditions for regulated drug manufacturing.

The material is packaged in sealed, desiccant-lined, tamper-evident containers to protect against moisture and degradation. Available in clinical, pilot, and commercial-scale quantities. Minimum order quantities (MOQ), lead times, and full regulatory documentation are provided upon request.

Each batch is tested for identity (IR, HPLC), assay, water content, specific optical rotation, heavy metals, residual solvents, and microbial purity. Certificates of Analysis (CoA), Safety Data Sheets (SDS), and full supporting analytical data accompany every shipment.

As with all CarboMer APIs, Esomeprazole Magnesium Trihydrate USP is supported by regulatory expertise, formulation assistance, and dependable global supply to help you advance safe and effective gastrointestinal therapies to market.