IndiaMart
FIEO
Esomeprazole Magnesium Dihydrate is the magnesium salt form of the S-isomer of omeprazole, classified as a proton pump inhibitor (PPI). It works by selectively inhibiting the H⁺/K⁺ ATPase enzyme in the gastric parietal cells, effectively suppressing gastric acid secretion. This API is extensively used in the formulation of medications for gastroesophageal reflux disease (GERD), peptic ulcer, erosive esophagitis, and Zollinger-Ellison syndrome.
At Bluepill Express, we manufacture and export high-purity Esomeprazole Magnesium Dihydrate API that complies with IP, BP, USP, and EP pharmacopeial standards. With a reputation for consistency, purity, and international quality compliance, our Esomeprazole API is widely used by global pharmaceutical companies for oral formulations such as enteric-coated tablets, capsules, and granules.
Our production process follows WHO-GMP and cGMP guidelines, ensuring batch-to-batch uniformity, precise particle size distribution, and excellent stability suitable for high-performance formulation development. Each batch is carefully analyzed by our in-house QC/QA team, using HPLC, IR, and titration methods to ensure complete compliance with international standards.
Pharmacological Information:
- Therapeutic Category: Proton Pump Inhibitor (PPI)
- Pharmacological Class: Gastric Acid Secretion Inhibitor
- CAS Number: 217087-10-0
- Molecular Formula: (C17H18N3O3S)2Mg·xH2O
- Molecular Weight: Approx. 767.2 g/mol (anhydrous basis)
- Appearance: White to off-white crystalline powder
- Solubility: Slightly soluble in methanol, sparingly soluble in water; freely soluble in alkaline solutions
- pH (1% suspension): 9.0 – 11.0
- Storage Conditions: Store below 25°C, protected from light and moisture
- Stability: Stable under recommended storage conditions
Mechanism of Action:
Esomeprazole, the S-enantiomer of omeprazole, acts by irreversibly inhibiting the H⁺/K⁺ ATPase enzyme system located in the gastric parietal cell membrane. By blocking this final step of acid production, it reduces both basal and stimulated gastric acid secretion, leading to significant and sustained suppression of stomach acidity.
This targeted mechanism makes Esomeprazole an effective and long-lasting treatment for acid-related disorders, offering better bioavailability and prolonged acid suppression compared to other PPIs.
Applications and Uses:
- Treatment of GERD (Gastroesophageal Reflux Disease)
- Healing of Erosive Esophagitis
- Management of Peptic Ulcers (gastric and duodenal)
- Prevention of NSAID-induced gastric damage
- Zollinger-Ellison Syndrome
- H. pylori Eradication Therapy (in combination with antibiotics)
- Formulation Base for Enteric-coated Tablets and Pellets
Formulation Applications:
- Esomeprazole 20 mg / 40 mg Tablets
- Enteric-coated Capsules / Pellets
- Esomeprazole Sachets (Granules for Suspension)
- Combination formulations:
- Esomeprazole + Domperidone
- Esomeprazole + Naproxen
- Esomeprazole + Amoxicillin + Clarithromycin (H. pylori therapy)
Technical Specifications:
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR spectrum conforms to reference standard |
| Assay (on dried basis) | 98.0% – 102.0% |
| Water Content (by KF) | 4.0% – 8.0% (corresponding to dihydrate) |
| Loss on Drying | ≤ 8.0% |
| pH (1% suspension) | 9.0 – 11.0 |
| Sulphated Ash | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | ≤ 0.2% (individual impurity) |
| Residue on Ignition | ≤ 0.1% |
| Particle Size Distribution | Optimized for uniform tablet formulation |
| Microbial Limits | Complies with pharmacopeial standards |
Quality Assurance & Manufacturing Standards – Bluepill Express
At Bluepill Express, our Esomeprazole Magnesium Dihydrate API manufacturing is carried out in state-of-the-art facilities certified under:
- WHO-GMP
- ISO 9001:2015
- cGMP-compliant production units
We employ advanced crystallization and purification processes to ensure superior physical properties such as controlled particle morphology, uniform flowability, and excellent compressibility, essential for enteric-coated tablet production.
Each production batch undergoes:
- HPLC and GC analysis for assay and impurity profiling
- Moisture content and pH determination
- Stability testing under accelerated conditions (ICH guidelines)
- Microbial limit test and heavy metal analysis
Our analytical team ensures all data is documented as per ICH Q7 and Regulatory Technical Files (DMF format) are available for export registration purposes.
Packaging & Export Information:
- Available Packaging: 1 kg / 5 kg / 10 kg / 25 kg HDPE drums with double poly liner protection
- Labeling: Export-compliant with product name, batch number, manufacturing & expiry date
- Shelf Life: 36 months (under recommended storage conditions)
- Documents Supplied:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data (on request)
- Non-GMO, BSE/TSE-Free Declaration
- Allergen-Free & Residual Solvent Certificate
Export Markets:
Bluepill Express supplies Esomeprazole Magnesium Dihydrate API across Asia, Africa, the Middle East, Latin America, and the CIS region, meeting both regulatory and client-specific requirements.
Regulatory & Compliance Information:
- Pharmacopeial Standards: IP / BP / USP / EP
- GMP Compliance: WHO-GMP Certified Facility
- DMF Support: Available on request for major markets
- REACH & RoHS: Compliant
- TSE/BSE-Free: Confirmed
- Residual Solvents: As per ICH Q3C guidelines
Safety Information:
- Hazard Statement: Non-toxic under normal handling; avoid inhalation and direct skin contact
- First Aid Measures: In case of contact, rinse with plenty of water; seek medical attention if irritation persists
- Handling & Storage: Store in a tightly closed container, away from light, heat, and moisture
