Pantoprazole Sodium is a substituted benzimidazole acting as a proton pump inhibitor (PPI). It suppresses the final step in gastric acid production by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. Supplied as a white to off-white crystalline powder, this API is synthesized via optimized multi-step processes designed to ensure high chemical purity and controlled crystal habit. It serves as the active pharmaceutical ingredient for oral enteric-coated solid dosages and sterile parenteral formulations targeting erosive esophagitis, Zollinger-Ellison syndrome, and related acid-peptic conditions.
Product Information
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Parameter |
Specification Details |
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Chemical Name |
Sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1H-benzo[d]imidazole sesquihydrate |
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CAS Number |
138786-67-1 (Sesquihydrate) / 102625-70-7 (Anhydrous) |
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Molecular Formula |
C16H14F2N3NaO4S · 1.5 H2O |
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Molecular Weight |
432.37 g/mol |
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Appearance |
White to off-white crystalline powder |
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Solubility |
Freely soluble in water, practically insoluble in n-hexane |
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Grade Standard |
USP / EP / BP compliant |
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Storage Condition |
Store in airtight containers, protected from light and moisture at controlled room temperature |
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Shelf Life |
36 months from the date of manufacture |
Quality & Specification
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Test Parameter |
Acceptance Criteria (USP / EP) |
Analytical Method |
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Assay (Dried Basis) |
98.0 % - 102.0 % |
High-Performance Liquid Chromatography (HPLC) |
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Appearance of Solution |
Clear and not more intensely colored than reference solution Y6 |
European Pharmacopoeia |
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Water Content |
5.5 % - 7.5 % (Sesquihydrate) |
Karl Fischer Titration |
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Heavy Metals |
≤ 20 ppm |
Colorimetric / ICP-MS |
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Residual Solvents |
Complies with ICH Q3C limits (Methanol, Dichloromethane, Acetone) |
Headspace GC |
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Related Substances |
Individual impurities ≤ 0.10 %; Total impurities ≤ 0.5 % |
Gradient HPLC |
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Residue on Ignition |
20.0 % - 25.0 % |
Gravimetric Analysis |
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Particle Size (D90) |
≤ 50 µm (Customizable via micronization) |
Laser Diffraction |
Manufacturing & Supply
Production Scale: Multi-ton annual manufacturing capacity utilizing dedicated glass-lined reactors and closed-system isolation units.
Process Control: In-process controls (IPCs) monitor reaction kinetics, crystallization temperature, pH levels, and drying parameters to maintain batch reproducibility.
Impurity Management: Advanced crystallization and purification stages eliminate residual intermediates and limit genotoxic impurity thresholds below ICH M7 guidelines.
Supply Capacity: Routine batch sizes available from pilot scale to commercial metric tons, supported by multi-facility production scheduling.
Documentation
Regulatory Support: Comprehensive Drug Master File (DMF) available for reference.
Batch Records: Certificate of Analysis (CoA) issued for every production batch, detailing all compendial testing parameters.
Compliance Dossiers: Complete data packages supporting stability studies (ICH guidelines: long-term, intermediate, accelerated), impurity profiles, and residual solvent declarations.
Statements Available: TSE/BSE-free, GMO-free, melamine-free, and elemental impurity reports per ICH Q3D.
Packaging
Primary Packaging: Double-layer low-density polyethylene (LDPE) bags tied securely and sealed under a positive pressure of nitrogen.
Secondary Packaging: Fiber drums or UN-approved HDPE drums with tamper-evident seals.
Net Weight: 25 kg per drum (customizable packaging configurations available upon request for specific formulation lines).
Labeling: Batch number, manufacturing date, retest date, net weight, gross weight, storage requirements, and manufacturer identification clearly marked on outer drums.
Pharmaceutical Application
Oral Delayed-Release Tablets: Used as the active core component in enteric-coated tablets, preventing acid degradation in the stomach and ensuring proximal intestinal absorption.
Gastroesophageal Reflux Disease (GERD): Formulated for the short-term treatment of erosion and ulceration associated with chronic acid reflux.
Zollinger-Ellison Syndrome: Applied in high-dose maintenance regimens for pathological hypersecretory conditions.
Intravenous Lyophilized Powder: Utilized in hospital settings for acute peptic ulcer bleeding or when oral administration is clinically unfeasible.
Combination Therapies: Incorporated into multi-drug eradication protocols targeting Helicobacter pylori infection alongside appropriate antibiotics.
FAQ
Q: What is the crystalline form of this Pantoprazole Sodium API?
A: The product is manufactured and supplied as the stable Pantoprazole Sodium Sesquihydrate form, confirmed by X-ray powder diffraction (XRPD) and differential scanning calorimetry (DSC).
Q: Can the particle size distribution (PSD) be adjusted for direct compression?
A: Yes, micronization services are available to meet specific particle size requirements (such as D90 < 20 \µm or custom ranges) to optimize downstream tableting performance.
Q: What regulatory documentation is provided to support generic drug filing?
A: A full open-part and closed-part DMF package is available for submission to regulatory authorities, alongside Letter of Access (LoA) issuance.
Q: How are shipments handled to ensure stability during long-distance transit?
A: Shipments are packed in light-resistant, moisture-barrier drums with desiccant protection, accompanied by transit stability validation data covering standard climatic zones.
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