INDOMETHACIN MICRONISED

Indomethacin Micronised is a non-steroidal anti-inflammatory drug (NSAID) widely used for the treatment of acute and chronic pain, inflammation, and fever. It is commonly prescribed for rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and gouty arthritis. The micronised form improves solubility, dissolution rate, and bioavailability, making it ideal for oral and injectable formulations.

At Bluepill Express, we manufacture and export pharmaceutical-grade Indomethacin Micronised API that complies with IP, BP, USP, and EP pharmacopeial standards. Produced under WHO-GMP, ISO, and cGMP-certified facilities, our product ensures high purity, consistent particle size, and superior stability, suitable for tablets, capsules, granules, and suspension formulations.

Each batch undergoes stringent quality control, including HPLC, IR spectroscopy, and microbial testing, guaranteeing pharmaceutical-grade reliability for global manufacturers.

Pharmacological Information:

• Therapeutic Class: Non-Steroidal Anti-Inflammatory Drug (NSAID)
• Pharmacological Category: COX Inhibitor
• CAS Number: 53-86-1
• Molecular Formula: C19H16ClNO4
• Molecular Weight: 357.79 g/mol
• Appearance: White to off-white crystalline powder
• Solubility: Slightly soluble in water, freely soluble in ethanol, acetone, and chloroform
• Melting Point: 158°C – 161°C
• Storage: Store in a cool, dry place, below 25°C, protected from light and moisture

Mode of Action:

Indomethacin acts by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, which reduces the synthesis of prostaglandins, leading to anti-inflammatory, analgesic, and antipyretic effects. The micronised formulation increases dissolution rate and absorption, enhancing therapeutic efficacy in oral and parenteral dosage forms.

Applications and Uses:

• Rheumatoid Arthritis & Osteoarthritis – Reduces joint pain, swelling, and stiffness
• Ankylosing Spondylitis – Alleviates spinal inflammation and pain
• Gouty Arthritis – Treats acute flares by reducing inflammation and discomfort
• Acute Pain & Postoperative Inflammation – Provides effective pain relief
• Pharmaceutical Formulations – Tablets, capsules, granules, suspensions, and injectables

Technical Specifications:

• Assay (Purity): ≥ 99.5%
• Identification: IR spectrum matches reference standard
• Loss on Drying: ≤ 0.5%
• Residue on Ignition: ≤ 0.1%
• Heavy Metals: ≤ 10 ppm
• Particle Size (Micronised): 10–30 microns (customizable)
• Related Substances: ≤ 0.2% (individual impurity)
• Microbial Limits: Complies with pharmacopeial specifications

Manufacturing & Quality Assurance – Bluepill Express:

• Manufactured under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities
• Micronised powder for improved bioavailability and uniform blending
• COA, MSDS, and TDS provided with each batch
• HPLC-tested for purity and stability
• Pharmacopeial compliance: IP / BP / USP / EP
• Suitable for oral, parenteral, and extended-release formulations

Packaging & Export Details:

• Available Packs: 1 kg, 5 kg, 10 kg, 25 kg HDPE drums with inner liner
• Shelf Life: 36 months from manufacturing date
• Labeling: Export-compliant with batch number and origin
• Export Markets: Africa, Europe, Asia, Middle East, Latin America
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Technical Data Sheet (TDS)
  • Stability Data (on request)
  • Non-GMO and Allergen-Free Declarations