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| Product Name | ( R )-Lansoprazole / Dexlansoprazole |
|---|---|
| CAS Number | 138530-94-6 |
| Appearance | White to brown-white powder |
| Key Properties | Improved pharmacokinetics, improved pharmacokinetics, dual delayed-release properties |
| Main Applications | GERD Treatment |
| Main Benefits | 1. Enantiomeric Purity |
Chemical Name: (R)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]-1H-benzimidazole
Common Name: Dexlansoprazole
CAS Number: 138530-94-6
Molecular Formula: C₁₆H₁₄F₃N₃O₂S | Molecular Weight: 369.36 g/mol
Form: White to brown-white crystalline powder
Dexlansoprazole is the (R)-enantiomer of Lansoprazole, a next-generation proton pump inhibitor (PPI) used to treat acid-related gastrointestinal conditions such as GERD, erosive esophagitis, and gastric ulcers.
Compared to racemic lansoprazole, (R)-lansoprazole offers improved pharmacokinetics, improved pharmacokinetics, dual delayed-release properties, and enhanced acid suppression over 24 hours, making it ideal for once-daily dosing.
| Parameter | Specification | Result |
|---|---|---|
| Appearance | White to brown-white powder | Complies |
| Solubility | Freely soluble in ethanol, soluble in acetonitrile, practically insoluble in water | Complies |
| Identification (IR) | Matches reference standard | Complies |
| Appearance of Solution | Clear, colorless or lighter than BY2 standard | Complies |
| Loss on Drying | ≤0.5% | <0.1% |
| Residue on Ignition | ≤0.1% | <0.1% |
| Heavy Metals | ≤0.001% | <0.001% |
| S-Isomer | ≤0.5% | 0.01% |
| Impurity B | ≤0.4% | 0.12% |
| Other Impurities | ≤0.10% each | 0.04% |
| Total Impurities | ≤0.6% | 0.19% |
| Residual Solvents | Meets ICH Q3C standards | All within limits |
| Assay (HPLC) | 98.0–102.0% | 100.9% |
Consists solely of the (R)-isomer of lansoprazole
Reduces variability, enhances therapeutic precision
Low S-isomer content (≤0.01%) ensures chiral stability and safety
Unique dual-pulse acid suppression over 24 hours
Optimized for once-daily dosing, improving patient adherence
Suitable for MUPS, enteric-coated granules, and extended-release capsules
Maintains gastric pH >4 for extended periods
Effective in both daytime and nighttime reflux episodes
Rapid symptom relief and mucosal healing, especially in erosive esophagitis
Higher bioavailability than racemic lansoprazole
Less subject to metabolic variation in CYP2C19 poor metabolizers
Reduced first-pass metabolism = more consistent plasma levels
Safe for long-term management of GERD, ulcers, and acid disorders
Frequently paired with amoxicillin + clarithromycin for H. pylori eradication
Also used with NSAIDs to prevent GI damage
Anhydrous Ethanol: Freely soluble
Acetonitrile: Soluble
Water: Practically insoluble
✅ Suitable for formulation in enteric-coated capsules, tablets, or granules
| Application | Target Users | Formulation Notes | Dosage |
|---|---|---|---|
| GERD Treatment | Adults with persistent heartburn | Dual delayed-release capsule | 30–60 mg/day |
| Erosive Esophagitis | Mucosal healing patients | Enteric-coated tablet or MUPS | 60 mg/day |
| H. pylori Triple Therapy | Infection-related ulcers | Co-administered with antibiotics | 30 mg BID |
| NSAID-induced Ulcers | Chronic pain/RA patients | Preventative co-formulation | 30 mg/day |
| Acid Hypersecretion (Zollinger-Ellison) | Specialty GI patients | Higher-dose controlled-release | As prescribed |
Chiral Resolution or Asymmetric Synthesis
→ Selection or synthesis of R-enantiomer precursor
Sulfoxidation Reaction
→ Specific formation of (R)-S=O bond (chiral sulfoxide center)
Intermediate Purification & Crystallization
→ Removal of S-isomer, achieving enantiomeric purity >99%
Final Conversion to Dexlansoprazole API
→ Acidification, filtration, drying
QC Testing & Release
→ HPLC (assay, impurities, enantiomer ratio), heavy metals, residual solvents
Packaging
→ Pharmaceutical-grade packaging under inert atmosphere (if required)
✔️ High Purity (100.9%), meets in-house and international pharma standards
✔️ Extremely low S-isomer content (0.01%) ensures chirally pure API
✔️ Controlled residual solvents and heavy metals
✔️ HPLC validated and GMP-compliant
✔️ Reliable production and batch-to-batch consistency
✔️ Suitable for solid oral dosage formulation (dual delayed-release possible)
Packaging: 1kg foil bag; 25kg fiber drum
Shelf Life: 2 years from manufacture date
Storage: Store in a cool, dry, sealed container protected from light
Unlike racemic lansoprazole, (R)-Lansoprazole delivers higher efficacy with lower isomer interference
Meets the demand for chirally pure, next-generation PPIs
Offers dual delayed-release mechanism for sustained acid suppression
Enables once-daily dosing with 24-hour symptom control, improving patient compliance
Used in advanced formats such as:
Modified-release (MR) capsules
MUPS (multi-unit pellet systems)
Enteric-coated tablets or dual-release beads
Global PPI market projected to exceed $4 billion+
Demand growing in OTC and Rx segments, especially in Asia-Pacific and Latin America
Dexlansoprazole-based products are patent-expired in many markets
Allows for generic ANDA/MA filings, or branded generic positioning
📈 Build a premium PPI line based on differentiated science and sustained-release formats
💰 Gain competitive edge in OTC and Rx proton pump inhibitor categories
🧪 Use in fixed-dose combinations with antibiotics, pain medications, or probiotics
📦 Secure, GMP-aligned API from a trusted supplier: Chibio Biotech
📧 Email: sales@chibiotech.com | 🌍 www.chibiotech.com | 📞 +86 532 66983270
✅ Chibio Biotech – Precision APIs. Trusted Quality. Global Reach.
Block B, Vanke Center, No.2 Heilongjiang South Road, Shibei District, Qingdao City, China 266033
+86 (0)532 66983270
+86 156 6577 2296
+86 133 8100 5417
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