Polmacoxib API is a synthetic non-steroidal anti-inflammatory active pharmaceutical ingredient belonging to the selective cyclooxygenase-2 (COX-2) inhibitor class. Polmacoxib is also known as CG100649 and has been developed for the management of inflammatory and painful conditions, particularly osteoarthritis. It is chemically identified by CAS Number 301692-76-2, molecular formula C₁₈H₁₆FNO₄S, and molecular weight 361.39 g/mol. PubChem and FDA GSRS records confirm the chemical identity and CAS number of Polmacoxib.
Polmacoxib is chemically named 4-[3-(3-fluorophenyl)-5,5-dimethyl-4-oxo-4,5-dihydrofuran-2-yl]benzenesulfonamide. The molecule contains a fluorophenyl group, sulfonamide functionality and a substituted furanone ring, giving it a distinct chemical structure within the COX-2 inhibitor class.
Polmacoxib is a small-molecule pharmaceutical API developed as a dual inhibitor of COX-2 and carbonic anhydrases. Its primary pharmacological relevance is associated with anti-inflammatory and analgesic activity. Research and pharmaceutical literature describe Polmacoxib as a non-steroidal anti-inflammatory agent investigated for osteoarthritis and other pain-related applications.
Polmacoxib was approved in South Korea in 2015 for the treatment of osteoarthritis and was commercialized as Acelex. A patent describing Polmacoxib identifies it as a COX inhibitor and NSAID and reports its approval by the Korean Ministry of Food and Drug Safety for osteoarthritis.
Polmacoxib has the following chemical characteristics:
PubChem reports the same molecular formula, CAS number and molecular weight, while Sigma-Aldrich describes commercial Polmacoxib as a powder with white-to-beige colour.
Polmacoxib is primarily associated with the treatment of osteoarthritis, where inhibition of COX-2 contributes to reduction of prostaglandin-mediated inflammation and pain.
Polmacoxib has also been investigated for its activity against carbonic anhydrases and for potential antineoplastic applications. Research has reported inhibition of colorectal adenoma and tumor growth in experimental models, although these research findings should not be interpreted as approved clinical indications.
Polmacoxib is therefore an important specialized API for pharmaceutical research and manufacturing applications involving selective COX-2 inhibition.
Quality control of Polmacoxib should focus on chemical identity, assay, related substances and physical characteristics. HPLC methods have been developed and validated specifically for Polmacoxib determination in bulk drug and pharmaceutical formulations.
Commercial analytical-grade Polmacoxib is available with ≥98% HPLC assay, while other research-grade material reports higher batch-specific purity, including 99.98%. These values demonstrate available analytical purity but should not automatically be represented as a universal pharmacopoeial release specification.
Published analytical work has demonstrated HPLC assay results around 100% for validated Polmacoxib analytical methods and has investigated related substances and degradation products.
As a Polmacoxib API Manufacturer in India, we focus on quality-controlled manufacturing and analytical characterization of Polmacoxib for pharmaceutical and research applications.
Polmacoxib requires appropriate control of assay, related substances, residual solvents and physical characteristics to maintain consistent API quality. HPLC-based analytical testing can be used for quantitative determination and impurity monitoring.
Our Polmacoxib API can be supported with batch-specific analytical documentation, product specifications and technical information according to applicable pharmaceutical and customer requirements.
Polmacoxib should be packaged in suitable pharmaceutical-grade, tightly closed containers designed to protect the material from moisture, contamination and excessive environmental exposure.
Commercial analytical-grade Polmacoxib is commonly stored under controlled temperature conditions. Sigma-Aldrich lists 2–8°C storage for its Polmacoxib research material, while other research suppliers recommend lower-temperature storage. Commercial API storage should therefore follow the manufacturer's validated stability data and approved specification rather than automatically applying research-grade storage conditions.
Typical documentation for Polmacoxib API may include:
Polmacoxib is a specialized COX-2 inhibitor with an established pharmaceutical development history and defined chemical identity. Its CAS Number 301692-76-2, molecular formula C₁₈H₁₆FNO₄S, and molecular weight 361.39 g/mol provide clear identification for pharmaceutical development and manufacturing.
For companies seeking a Polmacoxib API Manufacturer in India, quality-focused manufacturing, validated analytical testing and reliable batch documentation are important for maintaining consistent API quality.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.5% |
| Melting Point | 156.5°C |