Parecoxib Sodium API is the sodium salt of parecoxib and a selective cyclooxygenase-2 (COX-2) inhibitor prodrug. It belongs to the non-steroidal anti-inflammatory drug (NSAID) class and is used as a parenteral analgesic for the short-term management of postoperative pain. Parecoxib Sodium is converted in vivo to the active COX-2-selective compound valdecoxib.
Parecoxib Sodium has the molecular formula C19H17N2NaO4S, molecular weight 392.40 g/mol, and CAS Number 198470-85-8. The FDA Substance Registration System identifies Parecoxib Sodium under UNII EB87433V6F and confirms its chemical identity and CAS number.
TCI reports Parecoxib Sodium as a solid with molecular formula C19H17N2NaO4S, molecular weight 392.40, and CAS Number 198470-85-8.
Parecoxib Sodium is primarily associated with injectable pharmaceutical formulations for acute postoperative pain. Its water-soluble sodium salt form enables its use in parenteral formulations. Following administration, parecoxib is converted to valdecoxib, which selectively inhibits COX-2.
Applications include:
Parecoxib Sodium acts as a prodrug of valdecoxib. After administration, enzymatic hydrolysis converts parecoxib to valdecoxib. Valdecoxib selectively inhibits cyclooxygenase-2, reducing the production of prostaglandins associated with pain and inflammation.
Parecoxib Sodium is a sodium salt with the molecular formula C19H17N2NaO4S. It is generally described as a white to beige or white to light-yellow powder or crystalline solid depending on the reference and material grade. TCI reports the appearance as white to light-yellow powder to crystal, while Sigma-Aldrich reports a white-to-beige powder.
The compound is water-soluble compared with the free Parecoxib form. Sigma-Aldrich reports water solubility of approximately 2 mg/mL under its specified conditions, while other pharmaceutical references describe Parecoxib Sodium as a water-soluble injectable salt.
Parecoxib Sodium can be characterized using multiple analytical techniques, including:
A current Cayman Chemical certificate reports IR conforming, HPLC purity 100.0%, TLC purity 100%, and a UV maximum at 245 nm for its Parecoxib Sodium reference material.
Commercial analytical standards demonstrate high-purity Parecoxib Sodium materials. Sigma-Aldrich lists ≥98% HPLC, while TCI lists ≥95.0 area% HPLC for its research-grade product. These values are product-specific analytical specifications and should not be represented as a universal pharmacopoeial API release criterion.
For a pharmaceutical API specification, assay and related-substance acceptance criteria should be established according to the applicable regulatory filing, validated analytical method and approved manufacturing specification.
Parecoxib Sodium manufacturing requires appropriate control of organic impurities, residual solvents and elemental impurities. Published research specifically evaluated Cd, Pb, As, Hg, Co, V, Ni, Li, Sb and Cu in Parecoxib Sodium using ICP-MS and discussed their control under ICH Q3D. The study reported evaluated concentration limits of 0.2, 0.5, 1.5, 0.3, 0.5, 1, 2, 25, 9 and 30 ppm, respectively. These should be regarded as study/specification values rather than universal release limits because ICH Q3D limits depend on route, exposure and risk assessment.
Residual solvents should be evaluated according to the manufacturing process and applicable ICH Q3C requirements. Process-specific solvent controls may include solvents used during synthesis, extraction, purification and crystallization.
For commercial pharmaceutical API documentation, residual-solvent acceptance criteria should be based on the actual manufacturing process and validated analytical method rather than using unrelated research-grade values.
Parecoxib Sodium Bulk API is relevant to pharmaceutical manufacturers developing parenteral analgesic products. The API should be clearly identified as the sodium salt because Parecoxib and Parecoxib Sodium have different molecular formulas, molecular weights and chemical identities.
FDA's substance record specifically identifies Parecoxib Sodium and maps it to CAS 198470-85-8.
TCI recommends refrigerated storage at 0–10°C under inert gas for its research-grade material, while Sigma-Aldrich lists 2–8°C and desiccated storage for its product. These are supplier-specific storage conditions and should not automatically be treated as a universal bulk-API storage requirement.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| pH (1% Solution) | 7.5–8.5 (reported API specification) |
| Individual Impurity | NMT 0.5% |
| Melting Point | 273–275°C |