Omeprazole is a substituted benzimidazole acting as a proton pump inhibitor. It suppresses gastric acid secretion by specific inhibition of the hydrogen potassium ATPase enzyme system at the secretory surface of the gastric parietal cell. Supplied as a stable white to off-white crystalline powder, it serves as the foundational active pharmaceutical ingredient for oral and parenteral formulations indicated for gastroesophageal reflux disease, peptic ulcer disease, and pathological hypersecretory conditions.
Product Information
|
Parameter |
Specification Details |
|
International Nonproprietary Name |
Omeprazole |
|
Chemical Name |
6-methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-1H-benzimidazole |
|
CAS Number |
73590-58-6 |
|
Molecular Formula |
C17H19N3O3S |
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Molecular Weight |
345.42 g/mol |
|
Appearance |
White to off-white crystalline powder |
|
Solubility |
Soluble in dichloromethane, sparingly soluble in methanol and ethanol, practically insoluble in water |
|
Storage Conditions |
Store in airtight containers, protected from light and moisture, at controlled room temperature |
Quality and Specification
Identification: Infrared absorption spectrophotometry matches reference standard; high-performance liquid chromatography retention time conforms to principal peak.
Assay: 98.0 percent to 102.0 percent on dried basis.
Appearance of Solution: Clear and not more intensely colored than reference suspension.
Related Substances: Single impurity maximum 0.1 percent, total impurities maximum 0.5 percent.
Enantiomeric Purity: Conforms to chromatographic purity limits.
Loss on Drying: Maximum 0.5 percent.
Residue on Ignition: Maximum 0.1 percent.
Heavy Metals: Maximum 20 parts per million.
Residual Solvents: Methanol maximum 3000 parts per million, dichloromethane maximum 600 parts per million, acetone maximum 5000 parts per million.
Particle Size Distribution: Median diameter between 15 micrometers and 35 micrometers, ninety percentile below 75 micrometers.
Manufacturing Standards
Synthesis Route: Nucleophilic substitution and controlled catalytic oxidation stages avoiding heavy metal catalysts.
Purification Process: Multi-stage fractional crystallization in organic solvent systems ensuring low residual solvent profile.
Cleanroom Classification: ISO Class 8 isolation suites for crystallization, filtration, and micronization.
Batch Scale: Commercial production batches up to 500 kilograms per run ensuring high intra-batch and inter-batch uniformity.
Supply Lead Time: Standard ex-stock availability within two weeks; scheduled replenishment contracts available.
Documentation
Drug Master File: Available in open and closed part format for regulatory filings.
Certificate of Analysis: Provided with every commercial and analytical sample batch.
Certificate of Suitability: Available upon formal technical evaluation.
Good Manufacturing Practice: Issued by national regulatory authority.
Safety Data Sheet: Compliant with globally harmonized classification standards.
Stability Data: Long-term and accelerated data package available.
Genotoxic Impurity Evaluation: Risk assessment report completed per international council guidelines.
Packaging
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Primary Packaging |
Pharmaceutical grade low-density polyethylene bags, heat-sealed under nitrogen purge. |
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Secondary Packaging |
Light-protective black low-density polyethylene secondary tie bag. |
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Outer Protection |
Rigid fiber drum or corrugated aluminum-barrier fiber keg. |
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Standard Net Weight |
25 kilograms per drum, customizable down to 5 kilograms or 10 kilograms configurations. |
Pharmaceutical Application
Delayed-Release Capsules: Serves as the core active substance for enteric-coated pellet-filled capsules designed to bypass gastric acid degradation and ensure precise drug release profile in the proximal duodenum.
Enteric-Coated Tablets: Utilized in compressed core tablet technologies requiring sub-coating barriers to prevent acid-catalyzed degradation prior to intestinal absorption, compatible with standard enteric polymers.
Intravenous Injectable Lyophilized Powder: Applied in hospital settings for acute gastrointestinal bleeding and severe erosive esophagitis where oral administration is precluded, processed to meet strict endotoxin and sterility precursor requirements.
Pediatric Liquid Suspensions: Incorporated into formulated multi-particulate oral liquid delivery systems for pediatric populations requiring adjustable dosing regimens and accurate weight-based delivery.
FAQ
Q: What regulatory documentation supports the submission of Omeprazole API?
A: A comprehensive drug master file, certificate of suitability, and compliant stability data packages are fully accessible to support regional marketing authorization applications.
Q: How is polymorphic form stability controlled during micronization?
A: Crystallization parameters and milling energy inputs are strictly monitored using X-ray powder diffraction to maintain the targeted crystalline form without phase transitions.
Q: What are the standard storage and re-test intervals?
A: The material maintains stability for 36 months when stored in sealed containers protected from direct light and moisture at temperatures below 25 degrees Celsius.
Q: Can particle size distribution be customized for direct compression processes?
A: Mechanical milling parameters are adjustable to achieve specific particle size percentiles tailored to specific tableting or pelletization requirements.
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