Description

Simvastatin Impurity 3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Simvastatin, a widely prescribed cholesterol-lowering medication. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and quality control departments for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for meeting stringent pharmacopeial requirements and maintaining the integrity of the pharmaceutical supply chain.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Simvastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels and ensure product specifications are consistently met.
• Regulatory Compliance & Submissions: Essential for generating data to support regulatory filings (e.g., with FDA, EMA) by providing evidence of thorough impurity characterization and control.
• Stability Studies: Used to track the formation and levels of this specific impurity over time under various storage conditions, supporting drug shelf-life determination.
• Research & Development: Aids in chemical research focused on understanding the degradation pathways and synthesis by-products of Simvastatin.

Basic Information

Product Name	Simvastatin Impurity 3
CAS No.	288325-76-8
Molecular Formula	C25H38O5
Molecular Weight	418.57 g/mol
Synonyms	Simvastatin Related Compound C; Simvastatin EP Impurity C; (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; Simvastatin Hydroxy Acid Lactone; Dihydroxy Acid Lactone Impurity of Simvastatin; Simvastatin Lactone Impurity
EINECS	Contact for details

Quality Control

Our Simvastatin Impurity 3 is manufactured and tested under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques including HPLC, GC, MS, and NMR to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, related substances, and residual solvents. The material is suitable for use in applications requiring compliance with ICH Q3A/B guidelines and major pharmacopeias (USP, EP).

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) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment and handled under conditions that minimize exposure to ambient light and humidity to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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