Loxoprofen Sodium
| Parameter | Specification |
|---|---|
| Product Name | Loxoprofen Sodium |
| CAS Number | 80382-23-6 |
| Molecular Formula | C15H17NaO3 |
| Molecular Weight | 268.28 g/mol |
| Appearance | White to off-white crystalline powder |
| Assay (HPLC) | 98.0% – 102.0% (on dried basis) |
| Solubility | Freely soluble in water, soluble in methanol, slightly soluble in ethanol |
| Package | 25 kg fiber drum with double polyethylene liner |
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Synonyms: Sodium 2-[4-(2-oxocyclopentylmethyl)phenyl]propionate, Loxoprofen sodium salt, Loxonin, Loxoprofen sodium hydrate, 80382-23-6
Loxoprofen sodium has become a go-to active pharmaceutical ingredient for formulators targeting acute pain and inflammation. Unlike older NSAIDs that require high systemic doses, loxoprofen is a prodrug that converts to its active trans-alcohol metabolite, delivering potent analgesic and antipyretic effects with a notably lower gastrointestinal burden. This profile has fueled its inclusion in immediate-release tablets, sustained-release formulations, and topical patches across Asia and Latin America, with growing interest from European and North American generic developers.
Chemically, loxoprofen sodium is the sodium salt of 2-[4-(2-oxocyclopentylmethyl)phenyl]propionic acid. It belongs to the propionic acid class of NSAIDs and is synthesized through a multi-step process starting from p-isobutyl acetophenone. The sodium salt enhances aqueous solubility, making it suitable for both oral solid dosage forms and liquid-filled capsules. Our material is manufactured under cGMP conditions and is available as a white to off-white crystalline powder with a typical assay of 98.0–102.0% on the dried basis.
We supply loxoprofen sodium in commercial quantities with full regulatory support. Each batch is tested for identity, assay, related substances, residual solvents, and heavy metals to meet EP, USP, and JP monographs. Whether you are developing a generic tablet, a combination product, or a topical gel, our team can provide the documentation and technical assistance you need to move from bench to market efficiently.
Loxoprofen sodium is a nonsteroidal anti-inflammatory drug (NSAID) that acts as a prodrug. After oral administration, it is rapidly absorbed and hydrolyzed to its active metabolite, which inhibits cyclooxygenase (COX) enzymes, thereby reducing prostaglandin synthesis. This mechanism underpins its analgesic, antipyretic, and anti-inflammatory effects.
The active ingredient is present as the sodium salt, which improves water solubility and bioavailability. It is typically formulated as immediate-release tablets (60 mg or 120 mg) or as topical patches. Our API is produced via a proprietary synthesis route that minimizes impurities and ensures consistent particle size distribution for robust tableting.
| Test Item | Specification |
|---|---|
| Identification | IR and UV spectra conform to reference standard |
| Loss on Drying | ≤ 0.5% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | Total impurities ≤ 0.5%, individual ≤ 0.1% |
| Residual Solvents | Meets ICH Q3C limits |
| Microbial Limits | Total aerobic count ≤ 1000 CFU/g, absence of specified pathogens |
Our MOQ is 1 kg for sample evaluation and 25 kg for commercial orders. We can accommodate larger quantities based on your production needs.
For stock items, we ship within 3-5 business days after order confirmation. We maintain adequate inventory to ensure prompt dispatch.
Yes, we provide a COA for each batch and can supply samples for your testing. Please contact our sales team to request a sample and the corresponding COA.
send us your specification for a quotation.
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