Simvastatin EP Impurity A

Simvastatin EP Impurity A is chemically Sodium (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-dihydroxyheptanoate (as per EP). It is also known as Simvastatin USP Related Compound A ; Simvastatin Sodium ; Simvastatin Acid Sodium Salt ; Simvastatin Hydroxy Acid Sodium Salt ; Tenivastatin Sodium Salt. Simvastatin EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Simvastatin EP Impurity A can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Simvastatin.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.