Loxoprofen Sodium is the sodium salt of loxoprofen, a non-steroidal anti-inflammatory drug (NSAID) belonging to the propionic acid derivative class. It is used for its analgesic, anti-inflammatory and antipyretic properties.
Loxoprofen Sodium is a prodrug. Following oral administration, it is converted to its active trans-alcohol metabolite, which inhibits cyclooxygenase enzymes involved in the synthesis of prostaglandins. This provides relief from pain and inflammation.
Loxoprofen Sodium is a synthetic small-molecule pharmaceutical compound with the molecular formula C15H17NaO3 and a molecular weight of approximately 252.28 g/mol. Its CAS Number is 80382-23-6.
The compound is generally supplied as loxoprofen sodium hydrate in pharmaceutical applications. The sodium salt form provides suitable pharmaceutical characteristics for formulation.
Loxoprofen is converted in vivo to its active trans-alcohol metabolite. The active metabolite inhibits cyclooxygenase (COX) enzymes, reducing the conversion of arachidonic acid into prostaglandins.
Reduced prostaglandin production decreases peripheral pain signaling and inflammatory responses, resulting in analgesic and anti-inflammatory effects.
Loxoprofen Sodium is used in pharmaceutical formulations for the symptomatic treatment of pain and inflammation, including musculoskeletal pain, arthritis-related pain, dental pain, postoperative pain and other inflammatory conditions, depending on the approved indication.
It is commonly formulated as an oral tablet and may also be used in topical preparations in certain markets.
Loxoprofen Sodium API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residual solvents, elemental impurities and other applicable quality attributes.
Chromatographic and spectroscopic techniques may be used for identity, assay and purity determination. Appropriate controls should be established for related substances, degradation products and the applicable hydrate or solid-state characteristics.
Acceptance criteria should be based on the applicable manufacturer's drug-substance specification, Certificate of Analysis and relevant pharmacopoeial and regulatory requirements.
Loxoprofen Sodium should be stored in a tightly closed pharmaceutical-grade container under controlled conditions. It should be protected from excessive heat, moisture and direct light.
Specific storage and transportation requirements should follow the applicable manufacturer's approved specification.
Loxoprofen Sodium API may be supplied for qualified pharmaceutical manufacturing, formulation development, analytical and research applications, subject to applicable quality and regulatory requirements.
Loxoprofen Sodium API is available for qualified pharmaceutical development and manufacturing requirements subject to applicable quality and regulatory standards. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.
| 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 0.5% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |