Description

Simvastatin Acyl-B-D-Glucuronide is a key metabolite and reference standard of the widely prescribed cholesterol-lowering drug, simvastatin. This compound is essential for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily utilized by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in drug discovery and regulatory compliance activities.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the quantitative and qualitative analysis of simvastatin and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used to investigate the metabolic pathways, clearance rates, and bioavailability of simvastatin.
• Bioanalytical Method Development: Critical for developing and validating sensitive HPLC, LC-MS, or LC-MS/MS assays for clinical and preclinical studies.
• Impurity Profiling: Employed as a known impurity or degradation product standard to ensure drug substance and product purity per ICH guidelines.
• Toxicology and Safety Assessment: Aids in understanding the safety profile and potential toxicological implications of simvastatin metabolites.
• Regulatory Submissions: Provides essential data to support Investigational New Drug (IND) and New Drug Application (NDA) filings with agencies like the FDA and EMA.

Basic Information

Product Name	Simvastatin Acyl-B-D-Glucuronide
CAS No.	463962-56-3
Molecular Formula	C38H56O12
Molecular Weight	704.85 g/mol
Synonyms	Simvastatin β-D-Glucuronide; Simvastatin Acyl Glucuronide; Simvastatin Hydroxy Acid Glucuronide; (3R,5R)-7-((1S,2S,6R,8S,8aR)-8-(2-((2R,3R,4S,5S,6R)-3,4,5-Trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yloxy)-2-methylbutanoyloxy)-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)-3,5-dihydroxyheptanoic Acid; Simvastatin 6'-Glucuronide; Simvastatin Metabolite Standard
EINECS	Contact for details

Quality Control

Our Simvastatin Acyl-B-D-Glucuronide is manufactured under strict quality control protocols suitable for research and analytical use. Each batch is characterized using advanced spectroscopic and chromatographic techniques to ensure identity, purity, and stability. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing results for assay, purity, and related substances. Our quality system is designed to support GLP/GMP-compliant research, ensuring data integrity and reliability for critical pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability. Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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