Esomeprazole API Manufacturer & Supplier in India

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Esomeprazole API Manufacturer & Supplier in India

Esomeprazole is a proton pump inhibitor (PPI) and the S-enantiomer of omeprazole. It reduces gastric acid secretion by specifically inhibiting the gastric H⁺/K⁺-ATPase proton pump in the parietal cells of the stomach.

Esomeprazole is widely used as an active pharmaceutical ingredient in medicines for acid-related gastrointestinal disorders, including gastroesophageal reflux disease, peptic ulcer disease and conditions associated with excessive gastric acid secretion.

What is Esomeprazole?

Esomeprazole is a substituted benzimidazole derivative and belongs to the proton pump inhibitor class. It is commonly supplied in pharmaceutical products as esomeprazole magnesium or other approved salt forms.

The molecular formula of Esomeprazole is C₁₇H₁₉N₃O₃S, with a molecular weight of approximately 345.42 g/mol. The CAS Registry Number is 119141-88-7.

Mechanism of Action

Esomeprazole suppresses gastric acid production by inhibiting the H⁺/K⁺-ATPase enzyme system in gastric parietal cells.

This results in:

  • Reduction of basal gastric acid secretion
  • Reduction of stimulated acid secretion
  • Increase in gastric pH
  • Promotion of healing of acid-related mucosal damage

Esomeprazole is a prodrug that becomes activated in the acidic environment of the secretory canaliculi of gastric parietal cells.

Pharmaceutical Applications

Esomeprazole is primarily used in pharmaceutical formulations for:

  • Gastroesophageal reflux disease (GERD)
  • Erosive esophagitis
  • Peptic ulcer disease
  • Gastric and duodenal ulcer management
  • Helicobacter pylori eradication regimens in combination therapy
  • Prevention and treatment of NSAID-associated ulcers
  • Other acid-related gastrointestinal disorders

The exact approved indications depend on the applicable regulatory product labeling.

Esomeprazole API

Esomeprazole is a chiral small-molecule pharmaceutical API belonging to the proton pump inhibitor class. Its stereochemical purity is an important quality attribute because Esomeprazole represents the S-enantiomer of omeprazole.

Commercial pharmaceutical products may use different approved salt or formulation forms, including esomeprazole magnesium. Therefore, the API name, molecular formula, molecular weight and CAS number in your CMS should correspond to the exact form being supplied.

Quality & Regulatory Considerations

Pharmaceutical-grade Esomeprazole intended for manufacturing should comply with the applicable approved specification and relevant pharmacopoeial and regulatory requirements.

Typical quality-control parameters include:

  • Identification
  • Assay
  • Related substances
  • Enantiomeric purity
  • Water content
  • Residual solvents
  • Residue on ignition
  • Elemental impurities
  • Particle-size characteristics where applicable

A qualified supplier should provide Certificate of Analysis (CoA), specification sheet, SDS/MSDS, batch traceability and applicable regulatory documentation.

Storage

Esomeprazole should be stored in a tightly closed container, protected from excessive moisture, heat and direct light, according to the applicable approved storage and stability requirements.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
pH (1% Solution) 5.5 – 6.5
Individual Impurity NMT 0.5%
Water Content NMT 1.0%
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