Description

6'-Hydroxymethyl Simvastatin is a key pharmaceutical intermediate and a primary metabolite of the cholesterol-lowering drug Simvastatin. This compound matters for its critical role in the research, development, and synthesis of statin-based active pharmaceutical ingredients (APIs). It is essential for pharmaceutical manufacturers, R&D laboratories, and fine chemical suppliers focused on cardiovascular therapeutics and metabolic disease research.

Application

• Pharmaceutical Intermediate: Primary use in the synthesis of Simvastatin and related HMG-CoA reductase inhibitors.
• Active Pharmaceutical Ingredient (API) Research: Serves as a crucial metabolite for pharmacokinetic and pharmacodynamic studies.
• Reference Standard: Used as a certified reference material (CRM) in analytical method development and quality control laboratories.
• Biochemical Research: Employed in studies investigating cholesterol biosynthesis pathways and enzyme inhibition mechanisms.
• Process Development: Key starting material (KSM) or intermediate in optimizing commercial-scale API manufacturing processes.
• Impurity Standard: Utilized for the identification and quantification of related substances in Simvastatin drug substance and finished dosage forms.

Basic Information

Product Name	6'-Hydroxymethyl Simvastatin
CAS No.	128241-03-2
Molecular Formula	C26H40O7
Molecular Weight	464.59 g/mol
Synonyms	6'-Hydroxymethyl Simvastatin; Simvastatin Hydroxy Acid; 6'-Hydroxymethyl Simvastatin Acid; Simvastatin Metabolite; (3R,5R)-7-((1S,2S,6R,8S,8aR)-8-(2,2-Dimethylbutanoyloxy)-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)-3,5-dihydroxyheptanoic Acid; L-654,969; ZD-4522 (Metabolite); 6'-Hydroxymethylsynvinolin
EINECS	Contact for details

Quality Control

Our 6'-Hydroxymethyl Simvastatin is manufactured under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and identity confirmation. We provide full traceability and Certificates of Analysis (COA) are available for every batch, detailing all specified parameters. Production can be aligned with cGMP and ICH Q7 guidelines for pharmaceutical applications upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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