Description

2-Methyl Simvastatin (Mixture Of Diasteroisomers) is a key chemical intermediate and impurity standard used in the development and quality control of cholesterol-lowering pharmaceutical agents. This compound is critical for researchers and manufacturers who require high-purity reference materials to ensure the efficacy and safety of final drug products. It is primarily utilized by the pharmaceutical industry for analytical research, process development, and as a standard in regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a critical impurity standard and reference material for the analysis of Simvastatin and related statin drugs.
• Process Chemistry Research: Used in the research and development of synthetic pathways for statin-based active pharmaceutical ingredients (APIs).
• Analytical Method Development: Employed in HPLC, LC-MS, and other chromatographic methods for method validation and calibration.
• Quality Control & Assurance: Essential for impurity profiling and ensuring batch-to-batch consistency in pharmaceutical manufacturing under GMP guidelines.
• Metabolite Studies: Utilized in pharmacokinetic and metabolic pathway research for statin drugs.
• Regulatory Compliance Testing: Provides a benchmark for testing to meet stringent FDA, ICH, and pharmacopoeial (USP/EP) requirements.

Basic Information

Product Name	2-Methyl Simvastatin (Mixture Of Diasteroisomers)
CAS No.	774611-54-0
Molecular Formula	C26H40O6
Molecular Weight	448.60 g/mol
Synonyms	2-Methylsimvastatin; Simvastatin 2-Methyl Derivative; (1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-Hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate; 2-Methyl Simvastatin Diastereomer Mixture; Simvastatin EP Impurity F; Simvastatin Related Compound F
EINECS	Contact for details

Quality Control

Our 2-Methyl Simvastatin (Mixture Of Diasteroisomers) is produced and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical research and development. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profiles is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Keep the container tightly sealed in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
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.