Indomethacin is a high-purity nonsteroidal anti-inflammatory drug (NSAID) API widely used for pain, inflammation, and fever management. It works by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, which blocks the formation of prostaglandins responsible for pain, inflammation, and swelling.
Bluepill Express manufactures Indomethacin under WHO-GMP, ISO, and cGMP-certified facilities, ensuring exceptional purity, stability, and batch-to-batch consistency. This API is suitable for tablets, capsules, topical formulations, and injectables, meeting IP, BP, USP, and EP pharmacopoeial standards.
Therapeutic Classification
- Nonsteroidal anti-inflammatory drug (NSAID)
- Analgesic
- Antipyretic
- Anti-inflammatory agent
Mechanism of Action
Indomethacin inhibits COX-1 and COX-2 enzymes, reducing prostaglandin synthesis in inflamed tissues. This leads to:
- Reduction in pain
- Decrease in inflammation
- Alleviation of swelling and fever
It is commonly prescribed for arthritis, gout, ankylosing spondylitis, and musculoskeletal disorders.
Chemical & Composition Information
| Parameter | Details |
|---|---|
| Chemical Name | 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid |
| Molecular Formula | C19H16ClNO4 |
| Molecular Weight | 357.79 g/mol |
| CAS Number | 53-86-1 |
| Form | Crystalline powder |
| Pharmacopoeial Standards | IP / BP / USP / EP |
| Therapeutic Class | NSAID, Analgesic, Anti-inflammatory |
Physical & Chemical Properties
- Appearance: White to off-white crystalline powder
- Solubility: Slightly soluble in water, soluble in ethanol and methanol
- Melting Point: 158–160°C
- Stability: Chemically stable under recommended storage conditions
Technical Specifications (Bluepill Express Standards)
| Parameter | Specification |
|---|---|
| Assay | 98.0% – 102.0% |
| Identification | IR, UV, and HPLC spectra match reference standard |
| Water Content (KF) | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Related Substances | ≤ 0.5% individual impurity, ≤ 1.0% total impurities |
| Bulk Density | 0.35 – 0.55 g/ml |
| Particle Size Distribution | D90 < 250 μm (customizable) |
| Heavy Metals | ≤ 10 ppm |
| Microbial Limits | Complies with pharmacopeial standards |
Pharmacological Applications
- Pain management in arthritis and musculoskeletal disorders
- Treatment of gout and ankylosing spondylitis
- Relief from acute inflammation and fever
- Used in oral, topical, and injectable formulations
Dosage Forms
- Tablets: 25 mg, 50 mg, 75 mg
- Capsules: 25 mg, 50 mg
- Topical gels, ointments, and suppositories
Manufacturing Excellence – Bluepill Express
- WHO-GMP, ISO 9001:2015, and cGMP certified
- Controlled crystallization to ensure high purity
- Batch-to-batch uniformity in particle size, moisture, and assay
- Complete regulatory documentation: COA, MSDS, TDS, DMF-ready dossiers
- Export-ready API with reliable delivery and competitive pricing
Packaging & Storage
- Packaged in HDPE drums / fiber containers with PE liners
- Pack sizes: 5 kg / 10 kg / 25 kg
- Shelf Life: 36 months
- Storage: Store below 25°C, in a dry, cool environment, away from light and moisture
Safety & Handling
- Handle with gloves, mask, and protective goggles
- Avoid inhalation, ingestion, or direct contact with skin/eyes
- Follow GMP and EHS guidelines for handling and disposal
