Description

6(S)-Hydroperoxy Simvastatin is a key oxidized intermediate in the synthesis and metabolic study pathways of simvastatin, a widely prescribed cholesterol-lowering agent. This compound is of significant value for pharmaceutical research and development, particularly in the investigation of metabolic activation and degradation mechanisms. It serves as a critical reference standard and building block for researchers and manufacturers in the pharmaceutical and fine chemical industries focused on statin development and analytical method validation.

Application

• Pharmaceutical Reference Standard: Used as a high-purity certified reference material (CRM) for the identification and quantification of simvastatin metabolites and related substances in analytical methods like HPLC and LC-MS.
• Metabolic Pathway Research: Essential for studying the oxidative metabolic pathways and bioactivation mechanisms of simvastatin in pharmacological and toxicological research.
• Process Chemistry Intermediate: Acts as a crucial synthetic intermediate in the development and scale-up of novel simvastatin manufacturing processes or derivative compounds.
• Impurity Profiling: Employed to identify, characterize, and control potential oxidative degradants in simvastatin active pharmaceutical ingredient (API) and finished dosage forms to ensure product stability and safety.
• Academic & Institutional Research: Supports biochemical and medicinal chemistry research in universities and institutes focused on HMG-CoA reductase inhibitors and cardiovascular drug discovery.
• Quality Control Laboratories: Used by QC/QA labs in pharmaceutical companies to validate analytical procedures and ensure compliance with regulatory standards (e.g., ICH guidelines) for impurity testing.

Basic Information

Product Name	6(S)-Hydroperoxy Simvastatin
CAS No.	149949-01-9
Molecular Formula	C25H38O7
Molecular Weight	450.57 g/mol
Synonyms	6(S)-Hydroperoxy Simvastatin; 6(S)-OOH Simvastatin; Simvastatin 6(S)-Hydroperoxide; (1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-Hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2-methylbutanoate 6(S)-hydroperoxide; Simvastatin Hydroperoxide (6S-isomer)
EINECS	Contact for details

Quality Control

Our 6(S)-Hydroperoxy Simvastatin is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below under an inert atmosphere (e.g., argon or nitrogen) to minimize degradation due to its easily oxidized nature. For long-term storage, desiccate to protect against moisture. Allow the sealed container to reach room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.