Description

6-Oxo Simvastatin is a key pharmaceutical intermediate and a primary degradation product of the cholesterol-lowering drug Simvastatin. This compound is of significant importance in the pharmaceutical industry for analytical research, quality control, and the development of new active pharmaceutical ingredients (APIs). It is primarily utilized by manufacturers and research institutions involved in the synthesis, impurity profiling, and stability testing of statin-based medications.

Application

• Pharmaceutical Intermediate: A critical precursor in the synthesis and research of Simvastatin and related HMG-CoA reductase inhibitors.
• Reference Standard: Used as a certified reference material (CRM) for analytical method development, validation, and quality control in pharmaceutical laboratories.
• Impurity Profiling: Serves as a specified impurity standard for monitoring the degradation and stability of Simvastatin drug substances and finished products.
• Metabolite Studies: Employed in pharmacological and pharmacokinetic research to study the metabolic pathways of Simvastatin.
• Process Development: Used in the optimization and scale-up of manufacturing processes for statin APIs.
• Academic & Contract Research: A vital reagent for biochemical and medicinal chemistry research in academic and CRO (Contract Research Organization) settings.

Basic Information

Product Name	6-Oxo Simvastatin
CAS No.	130468-11-0
Molecular Formula	C25H38O6
Molecular Weight	434.57 g/mol
Synonyms	Simvastatin Impurity F (EP); Simvastatin Related Compound F (USP); 2,2-Dimethylbutanoic acid (4R,6R)-6-[2-[(1S,2S,6R,8S,8aR)-1,2,6,7,8,8a-hexahydro-8-hydroxy-2,6-dimethyl-1-naphthalenyl]ethyl]tetrahydro-4-hydroxy-2H-pyran-2-one-6-yl ester; 6-Keto Simvastatin; 6-Oxo Simvastatin Hydroxy Acid (lactone form); Simvastatin 6-Ketone; Simvastatin 6-Oxo Derivative
EINECS	Contact for details

Quality Control

Our 6-Oxo Simvastatin is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via IR and NMR, to ensure it meets high-purity standards suitable for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to meet specific pharmacopeial requirements (e.g., USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and opened under conditions of low humidity to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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