Description

Simvastatin Dimer CAS NO 476305-24-5 is a high-purity chemical reference standard and a key process-related impurity in the synthesis of Simvastatin, a widely prescribed cholesterol-lowering medication. This compound is critical for pharmaceutical research, development, and quality control, ensuring the safety and efficacy of the final drug product. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and regulatory compliance testing for statin-based therapies.

Application

• Primary use as a pharmaceutical reference standard for impurity identification and quantification in Simvastatin API and finished dosage forms.
• Essential for analytical method development and validation (HPLC, LC-MS) in quality control laboratories.
• Critical component in stability studies and forced degradation studies to understand drug product behavior.
• Used in regulatory submissions (e.g., for FDA, EMA) to characterize and control impurities as per ICH guidelines.
• Valuable research chemical for studying the metabolism and degradation pathways of statins.
• Serves as a process impurity marker during the optimization of Simvastatin manufacturing and purification processes.

Basic Information

Product Name	Simvastatin Dimer
CAS No.	476305-24-5
Molecular Formula	C49H78O10
Molecular Weight	827.15 g/mol
Synonyms	Simvastatin Dimer; Simvastatin Related Compound D; (3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-{2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl}-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid dimer; Simvastatin Impurity D; Bis-simvastatin; Dimeric Simvastatin
EINECS	Contact for details

Quality Control

Our Simvastatin Dimer is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical impurity analysis. Each batch is characterized and tested using advanced analytical techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual 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.