Description

Bazedoxifene Bis-β-D-Glucuronide is a major, pharmacologically active glucuronide metabolite of the selective estrogen receptor modulator (SERM) bazedoxifene. 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 utilized by research institutions, pharmaceutical companies, and contract research organizations (CROs) engaged in the development and regulatory filing of bazedoxifene-based therapies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of bazedoxifene and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic pathways, clearance mechanisms, and exposure levels of bazedoxifene in preclinical and clinical studies.
• Bioanalytical Method Development: Used as a critical standard to develop and validate sensitive LC-MS/MS or HPLC-UV methods for therapeutic drug monitoring and pharmacokinetic profiling.
• Impurity Profiling and Characterization: Employed in the identification and quantification of process-related impurities and degradation products in bazedoxifene active pharmaceutical ingredient (API) batches.
• Clinical Research Support: Provides a definitive standard for measuring metabolite concentrations in human plasma and serum during clinical trials for osteoporosis treatment and other indications.

Basic Information

Product Name	Bazedoxifene Bis-β-D-Glucuronide
CAS No.	328933-67-1
Molecular Formula	C44H52N2O16
Molecular Weight	864.90 g/mol
Synonyms	Bazedoxifene Bisglucuronide; Bazedoxifene D6-Bisglucuronide (related stable isotope); Bazedoxifene Glucuronide Metabolite; 1-[[4-[2-(Hexahydro-1H-azepin-1-yl)ethoxy]phenyl]methyl]-2-(4-hydroxyphenyl)-3-methyl-1H-indol-5-yl β-D-Glucopyranosiduronic Acid (1:2); TSE-424 Bisglucuronide; WAY-140424 Bisglucuronide
EINECS	Contact for details

Quality Control

Our Bazedoxifene Bis-β-D-Glucuronide is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical research. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, moisture-free environment. For long-term storage under inert atmosphere, sealing under argon or nitrogen is recommended. Allow the sealed vial to warm to room temperature before opening to minimize moisture condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC/MS)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines

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