Description

Simvastatin CAS NO 79902-63-9 is a potent, semi-synthetic statin derived from a fermentation product of *Aspergillus terreus*. This compound is a critical active pharmaceutical ingredient (API) primarily valued for its ability to effectively lower low-density lipoprotein (LDL) cholesterol and triglyceride levels in the blood. It is an essential raw material for global pharmaceutical manufacturers producing cholesterol-lowering medications. Its reliable efficacy and well-established safety profile make it a cornerstone in the management of hypercholesterolemia and the prevention of cardiovascular diseases.

Application

• Primary use as the Active Pharmaceutical Ingredient (API) in the formulation of oral solid dosage forms, most notably tablets, for cholesterol management.
• Manufacturing of generic and branded pharmaceutical products containing simvastatin as the sole therapeutic agent.
• Used in the research and development of fixed-dose combination drugs, often paired with other cardiovascular agents like ezetimibe.
• Critical raw material for pharmaceutical companies operating under cGMP (Current Good Manufacturing Practice) guidelines.
• Reference standard and analytical grade material for quality control laboratories in the pharmaceutical industry.
• Used in preclinical and clinical research studies investigating lipid metabolism and cardiovascular therapeutics.

Basic Information

Item	Detail
Product Name	Simvastatin
CAS No.	79902-63-9
Molecular Formula	C25H38O5
Molecular Weight	418.57 g/mol
Synonyms	Simvastatin; Synvinolin; MK 733; Zocor (brand name); (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; Sivastatin; Simvastatinum; Simvastatina
EINECS	Contact for details

Quality Control

Our Simvastatin is manufactured and tested to meet the stringent requirements of major pharmacopoeias, including USP (United States Pharmacopeia) and EP (European Pharmacopoeia) monographs. Every batch undergoes comprehensive analytical testing for identity, purity, potency, and specified impurities. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring full traceability and compliance with cGMP standards for pharmaceutical ingredient supply.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a low-humidity environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Meets EP/USP requirements
Heavy Metals	≤ 20 ppm
Microbial Limits	Meets EP/USP requirements

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