Description

6'-Hydroxy Simvastatin is a key pharmaceutical intermediate and metabolite of the cholesterol-lowering drug Simvastatin. This compound is of significant importance for research and development in the pharmaceutical industry, particularly in the study of drug metabolism, pharmacokinetics, and the synthesis of novel active pharmaceutical ingredients (APIs). It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic research institutions focused on cardiovascular therapeutics and analytical method development.

Application

• Pharmaceutical Intermediate: Critical starting material or precursor in the synthesis of Simvastatin and related HMG-CoA reductase inhibitors.
• Metabolite Reference Standard: Used as an analytical standard in bioanalytical studies to identify and quantify the 6'-hydroxy metabolite in biological samples for pharmacokinetic (PK) and pharmacodynamic (PD) profiling.
• Drug Metabolism Research: Essential for in-vitro and in-vivo studies to understand the metabolic pathways, efficacy, and safety profile of Simvastatin.
• Impurity Standard: Serves as a certified reference material (CRM) for quality control testing to monitor and control related substances in Simvastatin active pharmaceutical ingredient (API) batches.
• Process Development: Employed in the development and optimization of fermentation or synthetic manufacturing processes for statin drugs.
• Academic & Clinical Research: Used in university and hospital laboratories for fundamental research on cholesterol biosynthesis and cardiovascular disease mechanisms.

Basic Information

Product Name	6'-Hydroxy Simvastatin
CAS No.	134523-09-4
Molecular Formula	C25H38O6
Molecular Weight	434.57 g/mol
Synonyms	6'-Hydroxysimvastatin; Simvastatin 6'-Hydroxy Acid; (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 2,2-dimethylbutanoate; 6'-OH Simvastatin; Simvastatin Hydroxy Acid (6'-isomer); L-654,969; ZD-4522 (metabolite)
EINECS	Contact for details

Quality Control

Our 6'-Hydroxy Simvastatin is manufactured under strict quality management systems. Each batch undergoes comprehensive 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) detailing all test results are provided with every shipment.

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); ensure the container is sealed after each use to prevent degradation from atmospheric moisture.

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)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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