Description

Simvastatin Ep Impurity G is a high-purity reference standard used in the analytical profiling and quality control of Simvastatin, a widely prescribed cholesterol-lowering medication. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is essential for method development, validation, and routine testing in the production of active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Simvastatin Ep Impurity G in Simvastatin API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Critical for in-process testing and release testing of Simvastatin batches to ensure impurity levels are within specified pharmacopeial limits (e.g., USP, EP, BP).
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions (e.g., heat, humidity, light) as part of drug stability testing programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CMC documentation) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and chemical behavior of Simvastatin, aiding in the development of more stable formulations.

Basic Information

Product Name	Simvastatin Ep Impurity G
CAS No.	79902-62-8
Molecular Formula	C25H38O5
Molecular Weight	418.57 g/mol
Synonyms	Simvastatin EP Impurity G; Simvastatin Related Compound G; (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; 3''-Hydroxysimvastatin; 3-Hydroxysimvastatin; Simvastatin 3''-Hydroxy Acid; Simvastatin Hydroxy Acid Impurity
EINECS	Contact for details

Quality Control

Our Simvastatin Ep Impurity G is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity, purity, and strength. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results and confirming compliance with relevant pharmacopeial monographs (EP, USP) and ICH guidelines. Our quality commitment ensures reliability for your critical analytical and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This product is hygroscopic (moisture-sensitive). The container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

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 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.