Ketorolac Tromethamine is the tromethamine salt of ketorolac, a non-steroidal anti-inflammatory drug (NSAID) with potent analgesic activity. It is used as an active pharmaceutical ingredient in formulations intended for the short-term management of moderately severe acute pain.
Ketorolac works primarily by inhibiting cyclooxygenase enzymes and reducing the synthesis of prostaglandins, which are important mediators of pain and inflammation. Unlike opioid analgesics, Ketorolac does not produce its analgesic effect through opioid receptors.
Ketorolac Tromethamine is a salt formed from ketorolac and tromethamine. It has the molecular formula C19H24N2O6 and a molecular weight of 376.41 g/mol. Its CAS Number is 74103-07-4.
Ketorolac Tromethamine is generally supplied as a white to off-white crystalline powder. It is more water-soluble than the corresponding free acid, making the salt form suitable for pharmaceutical formulations.
Ketorolac Tromethamine inhibits cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing prostaglandin synthesis. The reduction in prostaglandins decreases peripheral sensitization of pain receptors and produces analgesic and anti-inflammatory effects.
Ketorolac Tromethamine is primarily used in pharmaceutical formulations for the short-term treatment of moderately severe acute pain. Depending on the formulation, it may be administered by parenteral, oral or ophthalmic routes according to approved product labeling.
Ketorolac Tromethamine API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residual solvents and other applicable quality attributes. HPLC and suitable spectroscopic techniques may be used for identification and purity assessment.
Acceptance criteria should be based on the applicable pharmacopoeial monograph or approved manufacturer's drug-substance specification and Certificate of Analysis.
Ketorolac Tromethamine should be stored in a tightly closed pharmaceutical-grade container under appropriate controlled conditions. The material should be protected from excessive heat, moisture, direct light and contamination. Specific storage requirements should follow the applicable manufacturer's specification.
Ketorolac Tromethamine API may be supplied for qualified pharmaceutical manufacturing, formulation development, research and analytical applications. Product specifications, Certificate of Analysis, packaging details and regulatory documentation should be confirmed according to the intended application.
Ketorolac Tromethamine API is available for pharmaceutical development and manufacturing requirements subject to applicable quality and regulatory requirements. Customers can request product specifications, analytical documentation, Certificate of Analysis, packaging information and commercial details for their specific requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Loss on Drying | NMT 1.0% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Melting Point | Approximately 162–166°C |