IndiaMart
FIEO
Naproxen Micronised is a nonsteroidal anti-inflammatory drug (NSAID) belonging to the propionic acid class. It exhibits anti-inflammatory, analgesic, and antipyretic properties, primarily indicated for pain management, arthritis, and musculoskeletal disorders.
The micronised grade ensures enhanced bioavailability, improved dissolution rate, and faster onset of action, making it ideal for tablet and capsule formulations.
At Bluepill Express, Naproxen Micronised is manufactured under WHO-GMP / cGMP-certified facilities, ensuring global quality standards and consistency suitable for regulated and semi-regulated markets.
Therapeutic Uses
- Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis
- Acute gout, tendinitis, bursitis
- Dysmenorrhea and mild to moderate pain
- Fever reduction and postoperative pain management
Mechanism of Action
Naproxen works by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing prostaglandin synthesis, which is responsible for inflammation, pain, and fever. The result is effective relief from musculoskeletal pain and joint inflammation.
Chemical & Pharmacological Information
- Chemical Name: (S)-6-Methoxy-α-methyl-2-naphthaleneacetic acid
- Molecular Formula: C14H14O3
- Molecular Weight: 230.26 g/mol
- CAS Number: 22204-53-1
- Therapeutic Category: Nonsteroidal Anti-inflammatory Drug (NSAID)
- Pharmacopoeial Grade: BP / USP / IP compliant
Physical & Chemical Properties
| Property | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Particle Size | Micronised grade for improved dissolution |
| Solubility | Practically insoluble in water; freely soluble in ethanol and methanol |
| Melting Point | 153°C – 158°C |
| Storage | Store below 25°C in a dry, cool, and dark place |
| Odor | Odorless or nearly odorless |
Technical Specifications (Typical Bluepill Express Standard)
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder |
| Identification | Positive by IR/UV |
| Assay (Purity) | ≥ 99.0% (HPLC) |
| Specific Rotation | +61° to +65° |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | ≤ 0.3% (individual impurity) |
| Bulk Density | 0.3 – 0.5 g/mL |
| pH (1% solution) | 6.0 – 8.0 |
All batches undergo rigorous in-house and third-party QC testing to ensure compliance with international pharmacopeia standards.
Applications
- Used as an active ingredient in the formulation of oral solid dosage forms such as tablets, capsules, and suspensions
- Preferred in micronised form for enhanced absorption and uniform plasma levels
- Commonly used in combination therapy with proton pump inhibitors (e.g., Naproxen + Esomeprazole)
Advantages of Bluepill Express Naproxen Micronised
- High bioavailability due to fine particle micronisation
- WHO-GMP & cGMP certified production
- Stringent impurity profile and high assay values
- Customized particle size distribution (PSD) as per client formulation need
- DMF support, COA, and stability data available for regulatory submissions
- Proven performance in both regulated and semi-regulated global markets
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data (ICH Q1A compliant)
- Regulatory Dossier / DMF (available upon request)
Packaging & Export Details
| Detail | Description |
|---|---|
| Available Packs | 1 kg / 5 kg / 10 kg / 25 kg HDPE drums or fiber containers with double poly liners |
| Labeling | Product name, batch number, MFG/EXP date, storage conditions, and regulatory markings |
| Shelf Life | 3–5 years (under recommended storage conditions) |
| Export Markets | Europe, Africa, Latin America, CIS, Middle East, and Asia |
