Description

Simvastatin Impurity 39 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the identification, quantification, and control of process-related impurities during the manufacturing of Simvastatin, a widely prescribed cholesterol-lowering medication. It is an essential material for analytical method development, validation, and quality assurance in pharmaceutical laboratories. Researchers and quality control professionals in the pharmaceutical and fine chemical industries rely on this impurity standard to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard 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 component in developing and validating HPLC, UPLC, and other chromatographic methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Simvastatin, meeting pharmacopeial standards (USP, EP).
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Simvastatin.
• Research & Development: Aids in process chemistry research to understand impurity formation pathways and optimize synthesis routes for purer Simvastatin production.

Basic Information

Product Name	Simvastatin Impurity 39
CAS No.	79902-42-4
Molecular Formula	C25H38O5
Molecular Weight	418.57 g/mol
Synonyms	Simvastatin Related Compound 39; Simvastatin EP Impurity J; (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; Dihydrosimvastatin Lactone; Simvastatin Lactone Impurity; 3-Hydroxy Simvastatin Lactone
EINECS	Contact for details

Quality Control

Our Simvastatin Impurity 39 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, GC, MS, and NMR to confirm identity and purity. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, spectral information, and batch-specific results. The material is suitable for use in methods requiring compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The container should be kept in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to prevent potential oxidation.

Specification

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

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