Indometacin API | NSAID Pharmaceutical API Manufacturer in India

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Indometacin API

Indometacin is a potent non-steroidal anti-inflammatory drug (NSAID) belonging to the indoleacetic acid derivative class. It is primarily used for its anti-inflammatory, analgesic and antipyretic properties and acts by inhibiting cyclooxygenase enzymes involved in prostaglandin synthesis.

Indometacin is used in pharmaceutical formulations for the management of various inflammatory and painful musculoskeletal conditions, as well as selected rheumatological and acute inflammatory disorders.

Indometacin API Manufacturer in India

Indometacin is a synthetic pharmaceutical API requiring controlled manufacturing, purification and analytical characterization. Quality control generally focuses on identity, assay, related substances, residual solvents, water content, elemental impurities and stability-related degradation products.

Chemical Information

CAS Number: 53-86-1
Molecular Formula: C19H16ClNO4
Molecular Weight: 357.79 g/mol
Chemical Name: Indometacin
Drug Class: Non-Steroidal Anti-Inflammatory Drug
Pharmacological Class: Cyclooxygenase Inhibitor
Therapeutic Class: Anti-inflammatory / Analgesic
Therapeutic Area: Rheumatology / Musculoskeletal Disorders

Mechanism of Action

Indometacin inhibits cyclooxygenase (COX) enzymes, particularly COX-1 and COX-2, which catalyze the conversion of arachidonic acid into prostaglandin precursors.

Reduced prostaglandin synthesis decreases inflammatory signaling and contributes to the drug's anti-inflammatory, analgesic and antipyretic effects.

Pharmaceutical Applications

Indometacin is used in pharmaceutical products for selected conditions including:

  • Rheumatoid arthritis
  • Osteoarthritis
  • Ankylosing spondylitis
  • Acute gouty arthritis
  • Bursitis and tendinitis
  • Other inflammatory musculoskeletal disorders
  • Pain and inflammation associated with selected conditions

Specific indications and formulations depend on applicable regulatory approvals.

Indometacin in Anti-Inflammatory Therapy

Indometacin is recognized as a potent NSAID and has historically been used where significant anti-inflammatory activity is required. Its pharmacological activity is primarily related to suppression of prostaglandin synthesis through COX inhibition.

Physical and Chemical Properties

Indometacin is a synthetic indole derivative containing chlorine, nitrogen and oxygen functional groups. It is generally supplied as a crystalline solid and exhibits limited aqueous solubility.

Its physicochemical properties are important considerations in formulation development, dissolution testing and analytical method development.

Quality and Analytical Testing

Indometacin API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Assay by HPLC
  • Related substances
  • Degradation products
  • Water content
  • Residual solvents
  • Residue on ignition
  • Elemental impurities
  • Heavy metals
  • Melting range
  • Particle-size distribution
  • Polymorphic characterization where applicable

Storage

Indometacin should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive moisture, heat and direct light. Final storage conditions should follow validated stability data.

Pharmaceutical Research and Development

Indometacin is relevant to pharmaceutical research involving:

  • NSAID drug development
  • Cyclooxygenase inhibition
  • Prostaglandin biosynthesis
  • Inflammation
  • Pain management
  • Rheumatology
  • Musculoskeletal disorders

Indometacin API Summary

Indometacin is a potent non-steroidal anti-inflammatory drug with CAS Number 53-86-1, molecular formula C19H16ClNO4, and molecular weight 357.79 g/mol. It inhibits cyclooxygenase enzymes and reduces prostaglandin synthesis, providing anti-inflammatory, analgesic and antipyretic effects.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.1%
Heavy Metals NMT 20 ppm
Individual Impurity NMT 1.0%
Total Impurities NMT 2.0%
Water Content NMT 1.0%
Melting Point 150–154°C
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