Omeprazole Sodium Api

Product Description

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Omeprazole Sodium API (Active Pharmaceutical Ingredient) Detailed Description

1. Chemical Information

• Name: Omeprazole Sodium

• IUPAC Name: 5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1H-benzimidazole sodium salt

• Molecular Formula: C17H18N3NaO3S

• Molecular Weight: ~367.39 g/mol

• CAS Number: 95510-70-6 (for the sodium salt)

• Synonyms: Omeprazole sodium salt, Prilosec sodium (brand name formulation)

2. Description

Omeprazole Sodium is the sodium salt form of omeprazole, a substituted benzimidazole compound. It belongs to a class of drugs known as proton pump inhibitors (PPIs). This compound is used primarily in the pharmaceutical industry for the formulation of oral and injectable medications intended to reduce stomach acid production.

Omeprazole Sodium is generally supplied as a white to off-white crystalline powder. It is freely soluble in water, which distinguishes it from omeprazole base, which is poorly soluble. This solubility makes it more suitable for certain formulations, such as intravenous (IV) preparations.

3. Mechanism of Action

Omeprazole sodium is a prodrug, which gets activated in the acidic environment of the parietal cells of the stomach. It irreversibly binds to and inhibits the H+/K+ ATPase enzyme system (proton pump) on the gastric parietal cell membrane, which is the final step in the acid secretion pathway. This inhibition results in a profound and prolonged reduction of gastric acid secretion.

4. Pharmacological Actions

• Therapeutic Class: Proton Pump Inhibitor (PPI)

• Pharmacodynamics: Reduces gastric acid secretion by inhibiting the H+/K+ ATPase enzyme

• Onset of Action: Typically within 1 hour

• Duration of Action: Up to 72 hours due to irreversible enzyme binding

5. Applications

Omeprazole Sodium is used in the treatment of:

• Gastroesophageal reflux disease (GERD)

• Peptic ulcers

• Zollinger-Ellison syndrome

• Erosive esophagitis

• NSAID-associated ulcers

• Helicobacter pylori eradication (in combination with antibiotics)

6. Formulation Uses

• Injectable omeprazole (IV use) for patients who cannot take oral medications

• Fast-dissolving or enteric-coated tablets

• Delayed-release capsules

7. Stability and Storage

• Omeprazole sodium is more chemically stable in alkaline conditions but is degraded rapidly in acidic environments, which is why it is typically formulated with enteric coatings for oral delivery or as lyophilized powders for injection.

• Store below 25C in a dry, light-protected environment

8. Regulatory and Quality Information

• Must comply with pharmacopeial standards (e.g., USP, EP)

• Common impurities include related benzimidazoles, sulfoxides, and degradation products

• Assay usually >98% on a dried basis

9. Manufacturing Considerations

• Requires protection from moisture and acidic conditions during synthesis and formulation

• Stability studies must include sensitivity to light, pH, and temperature