Ketorolac Trometamol API | NSAID Analgesic API Manufacturer in India

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Ketorolac Trometamol API

Ketorolac Trometamol is the tromethamine salt of ketorolac, a non-steroidal anti-inflammatory drug (NSAID) with potent analgesic activity. It is primarily used for the short-term management of moderately severe acute pain.

Ketorolac works mainly by inhibiting cyclooxygenase (COX) enzymes, reducing the synthesis of prostaglandins involved in pain and inflammation.

Ketorolac Trometamol API Manufacturer in India

Ketorolac Trometamol is a specialized analgesic and anti-inflammatory pharmaceutical API manufactured through controlled chemical synthesis and salt formation.

Important quality attributes include identity, assay, related substances, water content, residual solvents, elemental impurities, optical purity and stability.

Chemical Information

CAS Number: 74103-06-3
Molecular Formula: C15H13NO3·C4H11NO3
Molecular Weight: 376.41 g/mol
Drug Class: Non-Steroidal Anti-Inflammatory Drug (NSAID)
Pharmacological Class: Pyrrolo-pyrrole NSAID
Therapeutic Class: Analgesic / Anti-inflammatory
Therapeutic Area: Pain Management

Mechanism of Action

Ketorolac inhibits cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), reducing prostaglandin synthesis.

Reduced prostaglandin production decreases:

  • Pain signaling
  • Inflammatory responses
  • Tissue sensitization associated with acute pain

Ketorolac has strong analgesic activity relative to its anti-inflammatory effects.

Pharmaceutical Applications

Ketorolac Trometamol is used primarily for:

  • Short-term management of moderate to severe acute pain
  • Postoperative pain
  • Acute pain requiring non-opioid analgesia
  • Ophthalmic management of pain and inflammation in approved formulations

The route, duration and approved indications depend on the specific formulation and regulatory labeling.

NSAID Characteristics

Ketorolac is a non-opioid analgesic. Unlike opioid analgesics, its analgesic activity is primarily mediated through inhibition of prostaglandin synthesis.

Because of its safety profile, systemic ketorolac is generally intended for short-term use rather than long-term chronic pain management.

Manufacturing Process

Typical API manufacturing may involve:

  1. Preparation of pyrrolo-pyrrole intermediates
  2. Controlled chemical synthesis
  3. Functional-group transformations
  4. Purification
  5. Formation of the tromethamine salt
  6. Crystallization
  7. Filtration
  8. Drying
  9. Milling where required
  10. Final analytical testing
  11. Controlled packaging

Quality and Analytical Testing

Ketorolac Trometamol API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Assay
  • Related substances
  • Enantiomeric purity
  • Water content
  • Residual solvents
  • Elemental impurities
  • Residue on ignition
  • Melting range
  • Particle-size distribution where required
  • Stability testing

Storage

Ketorolac Trometamol should be stored in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage conditions should be established through validated stability studies.

Pharmaceutical Research and Development

Ketorolac Trometamol is relevant to research involving:

  • NSAIDs
  • COX inhibition
  • Acute pain management
  • Analgesic drug development
  • Postoperative pain
  • Ophthalmic formulations
  • Prostaglandin synthesis
  • Non-opioid analgesics

Ketorolac Trometamol API Summary

Ketorolac Trometamol is a tromethamine salt of ketorolac, with CAS Number 74103-06-3, molecular formula C15H13NO3·C4H11NO3, and molecular weight 376.41 g/mol. It is a potent NSAID analgesic primarily used for short-term treatment of moderate to severe acute pain.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification Conforms by IR and HPLC
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Total Impurities ≤ 1.5%
Water Content NMT 1.0%
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