Understanding the chemical profile of an Active Pharmaceutical Ingredient (API) like Parecoxib Sodium is fundamental for its effective use in drug development and manufacturing. This detailed look into its properties provides critical information for formulators, researchers, and quality control specialists.

Parecoxib Sodium, with the CAS number 198470-85-8, is chemically known as sodium N-[4-(5-methyl-3-phenyl-1,2-oxazol-4-yl)benzenesulfonyl]propanecarboximidate. Its molecular formula is C19H17N2NaO4S, and it has a molecular weight of approximately 394.42 g/mol. These precise chemical identifiers are crucial for accurate synthesis, analysis, and regulatory documentation.

Physically, Parecoxib Sodium API typically presents as a white to off-white crystalline powder. This powdery form is often preferred for its stability and ease of handling during the manufacturing process. Its solubility characteristics are noteworthy: it is described as freely soluble in water and methanol, and soluble in N,N-dimethylformamide. The water solubility is particularly important for its application as an injectable prodrug, allowing for easy reconstitution and administration.

Key physical properties such as melting point provide insights into its thermal stability. While specific values can vary slightly based on purity and crystal form, it generally exhibits a melting point in the range of 273-275°C, indicating a relatively stable solid form under normal storage conditions. The API is also noted to be hygroscopic, meaning it can absorb moisture from the air, necessitating proper storage in airtight containers under controlled atmospheric conditions, often at 2-8°C and protected from light.

The purity of Parecoxib Sodium API is a critical quality attribute, with specifications often requiring a minimum assay of 99%. Impurity profiling, including residual solvents and potential mutagenic impurities, must comply with stringent international guidelines such as ICH Q3C and ICH M8. These parameters are rigorously tested using analytical techniques like HPLC (High-Performance Liquid Chromatography) and GC (Gas Chromatography) to ensure the safety and efficacy of the final pharmaceutical product.

In summary, the detailed chemical and physical properties of Parecoxib Sodium API underscore its suitability for pharmaceutical applications. Manufacturers and researchers rely on this precise information to ensure quality control, optimize formulation processes, and comply with global regulatory standards, ultimately contributing to the delivery of safe and effective pain management therapies.