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Pantoprazole Sodium Sesquihydrate API is a proton pump inhibitor (PPI) used for the treatment of gastroesophageal reflux disease (GERD), peptic ulcer disease, Zollinger-Ellison syndrome, and other acid-related gastrointestinal disorders. It effectively suppresses gastric acid secretion by selectively inhibiting the H+/K+ ATPase enzyme in the stomach lining, providing relief from heartburn, acid reflux, and ulcer-related symptoms.
At Bluepill Express, we are a WHO-GMP, ISO 9001:2015, and cGMP-certified manufacturer and exporter of Pantoprazole Sodium Sesquihydrate API. Our API meets USP, BP, IP, and EP pharmacopeial standards, ensuring high purity, excellent stability, and consistent particle size suitable for oral, injectable, and combination pharmaceutical formulations.
Pantoprazole Sodium Sesquihydrate is widely used in enteric-coated tablets, oral granules, and intravenous preparations. Its stability in acidic conditions ensures optimal bioavailability and consistent therapeutic effect.
Therapeutic Applications:
- Gastroesophageal reflux disease (GERD)
- Peptic ulcers (gastric and duodenal)
- Erosive esophagitis
- Zollinger-Ellison syndrome
- Helicobacter pylori eradication (in combination therapy)
- NSAID-induced gastric damage prevention
Mechanism of Action:
Pantoprazole acts by irreversibly binding to the H+/K+ ATPase enzyme (proton pump) in the gastric parietal cells, blocking the final step of acid secretion. This leads to sustained reduction in gastric acid production, promoting healing of ulcers, esophagitis, and prevention of acid-related complications.
Technical Specifications:
- Chemical Name: Sodium 5-(Difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1H-benzimidazole sesquihydrate
- Molecular Formula: C₁₆H₁₄F₂N₃NaO₄S·1.5H₂O
- Molecular Weight: 383.38 g/mol (anhydrous)
- CAS Number: 102625-70-7
- Description: White to off-white crystalline powder
- Assay (on dried basis): NLT 98.0% and NMT 102.0%
- Melting Point: 196°C – 198°C
- Solubility: Freely soluble in water; soluble in ethanol; practically insoluble in methylene chloride
- Storage Conditions: Store in a tightly closed container below 30°C, protected from moisture and light
Pharmacological Classification:
- Therapeutic Class: Proton Pump Inhibitor (PPI) / Antiulcer Agent
- Pharmacopoeial Standards: IP / BP / USP / EP
- Dosage Form Applications:
- Enteric-coated tablets (20 mg, 40 mg)
- Oral granules and suspensions
- Intravenous injections
- Combination therapies with antibiotics or antacids
Quality & Manufacturing – Bluepill Express Standards:
- Produced in WHO-GMP, ISO, and cGMP-certified facilities
- High assay purity (≥99%) with minimal impurities
- Verified by HPLC, IR, and UV spectroscopic methods
- Batch-to-batch consistency and long-term stability
- Complies with USP/BP/IP pharmacopeial standards
- COA, MSDS, and DMF available upon request
Advantages of Bluepill Express Pantoprazole Sodium API:
- High purity and solubility for optimal bioavailability
- Regulatory-ready API for international export
- Consistent particle size and flow properties for tableting and encapsulation
- Reliable bulk supply for large-scale manufacturing
- Extended shelf-life under recommended conditions
Packaging & Export Details:
- Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with LDPE inner liner
- Shelf Life: 3 years under recommended storage conditions
- Labeling: Compliant with international pharmacopeial and export regulations
- Export Markets: Europe, Africa, Asia-Pacific, Middle East, Latin America
- Documentation Provided:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Drug Master File (DMF – on request)
- Stability and regulatory compliance certificates
