Description

Pitavastatin Acyl Glucuronide is a key metabolite of the cholesterol-lowering drug Pitavastatin, formed via the glucuronidation pathway. This compound is of critical importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics (PK), and bioanalytical method validation. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in drug discovery, ADME (Absorption, Distribution, Metabolism, and Excretion) studies, and the development of regulatory-compliant analytical assays.

Application

• Reference Standard for Bioanalysis: Used as a certified standard in LC-MS/MS and HPLC methods for quantifying Pitavastatin and its metabolites in biological matrices (plasma, serum, urine).
• Metabolite Identification & Profiling: Essential for characterizing the metabolic pathways of Pitavastatin in preclinical and clinical studies.
• Pharmacokinetic (PK) and Toxicokinetic (TK) Studies: Serves as a critical analyte to understand the drug's clearance, exposure, and safety profile.
• DMPK (Drug Metabolism and Pharmacokinetics) Research: A vital tool for investigating drug-drug interaction potentials involving glucuronidation enzymes (UGTs).
• Method Development and Validation: Used to develop, optimize, and validate analytical methods in compliance with GLP (Good Laboratory Practice) and ICH guidelines.
• Impurity Standard: Can be utilized as a known impurity or degradation product standard for quality control of Pitavastatin active pharmaceutical ingredient (API).

Basic Information

Product Name	Pitavastatin Acyl Glucuronide
CAS No.	574752-66-2
Molecular Formula	C₃₀H₃₅FNO₁₀
Molecular Weight	588.60 g/mol
Synonyms	Pitavastatin 1-O-β-Acyl Glucuronide; (3R,5S,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxy-6-heptenoic Acid 1-β-Glucuronide; Pitavastatin Glucuronide; NK-104 Glucuronide; Livalo® Metabolite; Pitavastatin Acyl-β-D-Glucuronide
EINECS	Contact for details

Quality Control

Our Pitavastatin Acyl Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, LC-MS, and NMR to ensure identity, purity, and stability. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data. We support research requiring compliance with various pharmacopeial and regulatory standards.

Storage

Preserve in a tightly closed container, protected from light. For long-term storage, keep at -20°C or below. The product is hygroscopic (moisture-sensitive) and should be allowed to equilibrate to room temperature in a dry environment 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.