Simvastatin EP Impurity A

Streamline your structural degradation monitoring with Simvastatin EP Impurity A, expertly synthesized by Manasa Life Sciences, a leading global manufacturer and supplier of pharmaceutical reference standards. Recognized by its regulatory designation Simvastatin EP Impurity A, this compound represents the open-ring Simvastatin hydroxy acid form with the CAS Number 121009-77-6, molecular formula C₂₅H₄₀O₆ and a molecular weight of 436.58 g/mol and chemical name (3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-[(2,2-Dimethylbutanoyl)oxy]-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic Acid. Our GMP-compliant facility isolates this critical Simvastatin open ring impurity to assist laboratories in achieving complete compliance with international EP and USP monographs. Each shipment includes an exhaustive COA, structural NMR validation data, and a safety-verified MSDS to satisfy strict GDP requirements. Validated using high-resolution HPLC and ultra-sensitive LCMS equipment, this Simvastatin Impurity A reference compound maps out raw degradation behaviors according to ICH stability testing criteria. By integrating our certified standard into your testing workflows, you ensure your analytical dossiers stay fully aligned with USFDA and EMA data review processes.