Description
High Quality Montelukast Sodium API | Pharmaceutical Grade USP
Product Overview
Montelukast Sodium API is a high-purity, pharmaceutical-grade active pharmaceutical ingredient (API) used primarily in the treatment of asthma and allergic rhinitis. As a selective leukotriene receptor antagonist, it plays a critical role in controlling inflammatory responses in the respiratory system.
Our Montelukast Sodium is manufactured under strict GMP conditions, complying with USP (United States Pharmacopeia) standards. It is ideal for generic drug manufacturers, formulation laboratories, and pharmaceutical companies seeking a reliable, high-quality raw material for anti-asthmatic preparations.
Key Specifications
| Parameter | Details |
|---|---|
| Product Name | Montelukast Sodium API |
| CAS Number | 158966-92-8 |
| Molecular Formula | C₃₅H₃₅ClNNaO₃S |
| Molecular Weight | 608.17 g/mol |
| Grade | Pharmaceutical Grade, USP/EP Compliant |
| Assay (HPLC) | ≥ 99.0% |
| Appearance | White to off-white crystalline powder |
| Shelf Life | 3 years when stored under proper conditions |
| Storage | Tight container, protected from light and moisture, stored at controlled room temperature |
Therapeutic Applications
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Asthma – Prophylaxis and chronic treatment of asthma in adults and pediatric patients.
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Allergic Rhinitis – Relief of symptoms of seasonal and perennial allergic rhinitis.
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Exercise-Induced Bronchoconstriction – Prevention of bronchospasm.
Montelukast Sodium acts by inhibiting the cysteinyl leukotriene receptor (CysLT1), thereby reducing airway edema, smooth muscle contraction, and inflammatory cell infiltration.
Product Advantages
✅ High Purity – HPLC assay ≥ 99.0%, meeting strict USP impurity profiles.
✅ GMP Certified Facility – Manufactured in a facility audited to international GMP standards.
✅ Stable Supply Chain – Large-scale production capacity ensures consistent availability for bulk orders.
✅ Complete Documentation – Available with DMF (Drug Master File), COA, stability data, and regulatory support.
✅ Competitive Pricing – Direct from manufacturer, offering cost advantages for generic drug production.
Quality Control & Compliance
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USP Grade – Every batch is tested for identity, purity, potency, and residual solvents in accordance with USP monographs.
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Stability Testing – Long-term and accelerated stability studies ensure product integrity throughout shelf life.
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Residual Solvents – Controlled according to ICH Q3C guidelines.
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Microbial Limits – Strictly controlled to meet pharmaceutical safety requirements.
Packaging & Shipping
| Packaging Type | Specification |
|---|---|
| Standard | 1 kg, 5 kg, 10 kg, 25 kg aluminum foil bags or fiber drums |
| Customization | Available upon request |
| Shipping | Ambient temperature, sealed to protect from moisture and light |
We ensure safe, tamper-proof packaging with detailed batch-specific labeling.
Why Choose Us?
As a leading manufacturer of Montelukast Sodium API, we combine technical expertise with reliable service. Our team provides:
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Prompt technical support for formulation development
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Regulatory assistance for DMF filing
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Flexible MOQ for both R&D and commercial quantities
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Timely delivery with global export experience
Contact Us
For inquiries, samples, or to request a quote for Montelukast Sodium API (CAS 158966-92-8) , please contact us directly. We look forward to supporting your pharmaceutical projects with quality and reliability.
Tags: *Montelukast Sodium API, Montelukast Sodium, CAS 158966-92-8, USP grade API, pharmaceutical grade, anti-asthmatic API, GMP manufacturer, active pharmaceutical ingredient, asthma raw material, Montelukast powder
