Description

Simvastatin Acid CAS NO 121009-77-6 is the primary active metabolite of the widely prescribed cholesterol-lowering drug, Simvastatin. This high-purity intermediate is critical for pharmaceutical research and development, particularly in the synthesis of novel statin derivatives and for analytical reference standards. It is essential for manufacturers and R&D laboratories in the pharmaceutical and biotechnology sectors focused on cardiovascular therapeutics and metabolic disease research.

Application

• Pharmaceutical Intermediate: Key starting material (KSM) or advanced intermediate in the synthesis of Simvastatin and related HMG-CoA reductase inhibitors.
• Reference Standard: Certified reference material (CRM) for quality control and analytical method development in pharmaceutical manufacturing.
• Metabolite Studies: Used in pharmacokinetic and pharmacodynamic research to study the metabolism and efficacy of Simvastatin.
• Impurity Profiling: Serves as a critical impurity standard for HPLC and LC-MS analysis to ensure drug purity and compliance with ICH guidelines.
• Biochemical Research: Tool compound for in vitro studies investigating the mechanism of action of statins on cholesterol biosynthesis pathways.
• Generic Drug Development: Essential for companies developing generic versions of Simvastatin, ensuring bioequivalence and regulatory compliance.

Basic Information

Product Name	Simvastatin Acid
CAS No.	121009-77-6
Molecular Formula	C25H38O5
Molecular Weight	418.57 g/mol
Synonyms	Simvastatin 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 (2S)-2-methylbutanoate; L-654,969; MK 0733; Zocor Acid; Synvinolin Acid; Velastatin Acid
EINECS	Contact for details

Quality Control

Our Simvastatin Acid is manufactured under strict quality management systems. Each batch is tested to meet high-purity standards suitable for pharmaceutical R&D and reference standard applications. We provide comprehensive Certificates of Analysis (COA) detailing purity, identity, and impurity profiles, with testing performed via validated methods such as HPLC, NMR, and MS. The product is suitable for use under cGMP guidelines for non-clinical research.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storage under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0%
Single Maximum Unknown Impurity	≤0.5%
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.