Description

Pitavastatin 3-Ether Glucuronide is a key glucuronide metabolite of the cholesterol-lowering drug Pitavastatin. This compound is of critical importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in the development and regulatory submission of generic or novel statin-based therapies.

Application

• Reference Standard for Bioanalysis: Serves as a critical certified reference material (CRM) for the quantitative analysis of Pitavastatin and its metabolites in biological matrices (plasma, urine) using LC-MS/MS or HPLC.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used to investigate the metabolic pathways, clearance mechanisms, and excretion profiles of Pitavastatin in preclinical and clinical research.
• Impurity Profiling and Characterization: Employed as an identified impurity standard to monitor and control the quality of Pitavastatin active pharmaceutical ingredient (API) during manufacturing.
• Toxicology and Safety Assessment: Facilitates studies on the safety profile of Pitavastatin metabolites to fulfill regulatory requirements for drug approval.
• Enzyme Reaction Studies: Used as a substrate or standard in vitro studies to understand the activity of UDP-glucuronosyltransferase (UGT) enzymes involved in Phase II drug metabolism.
• Method Development and Validation: Essential for developing, qualifying, and validating robust analytical methods in compliance with ICH, FDA, and EMA guidelines.

Basic Information

Product Name	Pitavastatin 3-Ether Glucuronide
CAS No.	224320-11-0
Molecular Formula	C₃₀H₃₆FNO₁₀
Molecular Weight	589.61 g/mol
Synonyms	Pitavastatin 3-O-Glucuronide; Pitavastatin Glucuronide; (3R,5S)-7-(2-Cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid 3-O-β-D-glucuronide; Livalo Glucuronide Metabolite; NK-104 Glucuronide; Pitavastatin Acyl Glucuronide; Pitavastatin 3-O-β-D-Glucuronide
EINECS	Contact for details

Quality Control

Our Pitavastatin 3-Ether Glucuronide is manufactured under strict quality control protocols suitable for research and reference standard applications. Each batch is characterized using advanced analytical techniques including HPLC, LC-MS, and NMR to confirm identity and purity. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, and our quality system supports compliance with relevant pharmacopeial and ICH guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. This compound is hygroscopic (moisture-sensitive); allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

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 limits

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