Description

Atorvastatin Acyl-B-D-Glucuronide is a major, pharmacologically relevant metabolite of the widely prescribed statin drug, atorvastatin. This compound is of critical importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and the potential for drug-drug interactions. It serves as an essential reference standard and analytical tool for scientists and quality control laboratories in the pharmaceutical and biotechnology sectors, ensuring accurate measurement and understanding of atorvastatin's metabolic profile.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the quantitative and qualitative analysis of atorvastatin metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Critical for in vitro and in vivo studies to elucidate the metabolic pathways, clearance mechanisms, and half-life of atorvastatin.
• Bioanalytical Method Development and Validation: Used as a key calibrant and quality control sample in developing LC-MS/MS, HPLC, and other chromatographic assays for clinical and preclinical trials.
• Toxicology and Safety Assessment: Employed in studies to assess the potential toxicity or unique biological activity of atorvastatin glucuronide metabolites.
• Impurity Profiling and Characterization: Acts as an identified impurity standard in the quality control of atorvastatin active pharmaceutical ingredient (API) and finished dosage forms to meet ICH guidelines.
• Academic and Institutional Research: Fundamental for basic research on statin pharmacology, glucuronidation enzymes (UGTs), and personalized medicine approaches.

Basic Information

Product Name	Atorvastatin Acyl-B-D-Glucuronide
CAS No.	463962-58-5
Molecular Formula	C39H43FN2O11
Molecular Weight	734.77 g/mol
Synonyms	Atorvastatin Acyl-β-D-Glucuronide; Atorvastatin O-Acyl Glucuronide; (3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid β-D-Glucopyranosiduronic Acid; Atorvastatin 1-O-β-Glucuronide; Atorvastatin Acyl Glucuronide Metabolite; Atorvastatin AG; AAG
EINECS	Contact for details

Quality Control

Our Atorvastatin Acyl-B-D-Glucuronide is manufactured and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical research and reference standards. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. Allow the sealed container to equilibrate to room temperature before opening to prevent moisture condensation. For short-term use, store at 2-8°C.

Specification

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

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