Product Description
Simvastatin ammonium salt ≥98.0% API Simvastatin Intermediate made in china 139893-43-9
AI Product Description
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Simvastatin Ammonium Salt, a high-purity pharmaceutical intermediate with a purity of ≥98.0%, is a critical precursor in the synthesis of Simvastatin, a widely prescribed HMG-CoA reductase inhibitor used to manage hypercholesterolemia and reduce cardiovascular risk. Manufactured primarily in China by leading chemical suppliers, this compound serves as an essential building block for large-scale API production, ensuring consistency and efficiency in the global pharmaceutical supply chain. The molecular formula of Simvastatin Ammonium Salt is typically represented as C25H36NO7·NH3, reflecting its structure as the ammonium adduct of simvastatin acid, though exact stoichiometry may vary slightly depending on the specific hydration state or salt formation method employed during synthesis. Its CAS number is 114950-98-6, which distinguishes it from other salts or free acid forms of simvastatin and facilitates precise identification in regulatory filings and quality control protocols.
This intermediate is characterized by high solubility in polar organic solvents and excellent stability under standard storage conditions, making it ideal for industrial-scale conversion into the active pharmaceutical ingredient (API). As a key component in the semi-synthesis pathway of Simvastatin, it undergoes controlled reactions to yield the final drug substance with minimal impurities, adhering to stringent International Council for Harmonisation (ICH) guidelines. Pharmaceutical manufacturers favor Chinese-sourced Simvastatin Ammonium Salt due to competitive pricing, robust manufacturing infrastructure, and compliance with Good Manufacturing Practice (GMP) standards. The product is extensively utilized by generic drug producers worldwide to formulate statin medications targeting lipid-lowering therapy. Beyond clinical applications, it supports research initiatives focused on cardiovascular disease mechanisms and novel drug delivery systems. Regulatory agencies require detailed documentation of origin and purity for this intermediate, underscoring its importance in maintaining drug safety and efficacy. With growing demand for affordable cholesterol management therapies globally, the role of high-quality Simvastatin Ammonium Salt intermediates remains indispensable in modern pharmacotherapy, bridging raw material science with life-saving medical outcomes across diverse healthcare markets.