Description

Bicalutamide o-β-D-Glucuronide is a major, inactive metabolite of the non-steroidal anti-androgen drug bicalutamide, formed via glucuronidation. This compound is of critical importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It serves as an essential reference standard for laboratories in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors requiring precise quantification and characterization of bicalutamide and its metabolic pathways.

Application

• Pharmaceutical Reference Standard: Primary use as a high-purity certified reference material (CRM) for quantitative analysis in drug development and quality control.
• Metabolite Identification & Profiling: Critical for in vitro and in vivo studies to map the metabolic fate of bicalutamide, supporting ADME (Absorption, Distribution, Metabolism, Excretion) research.
• Bioanalytical Method Development: Used as a calibration standard and for validation of LC-MS/MS, HPLC, and other analytical methods in biological matrices.
• Pharmacokinetic (PK) Studies: Enables accurate measurement of metabolite levels in plasma, serum, and urine to understand exposure and clearance rates.
• Impurity Characterization: Serves as a known impurity or degradation product standard for the stability testing and specification setting of bicalutamide active pharmaceutical ingredient (API).
• Clinical Research: Supports studies investigating inter-patient variability in drug metabolism and the potential for drug-drug interactions.

Basic Information

Product Name	Bicalutamide o-β-D-Glucuronide
CAS No.	151262-59-8
Molecular Formula	C26H31F4N2O8S
Molecular Weight	607.60 g/mol
Synonyms	Bicalutamide Glucuronide; Bicalutamide O-Glucuronide; Bicalutamide 4'-O-β-D-Glucuronide; (RS)-N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanamide O-β-D-Glucuronide; Bicalutamide Metabolite; Bicalutamide M1; Casodex Metabolite
EINECS	Contact for details

Quality Control

Our Bicalutamide o-β-D-Glucuronide is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring traceability and compliance with research-grade standards. We support compliance with ICH guidelines for stability and impurity profiling.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dedicated freezer. This compound is hygroscopic (moisture-sensitive); allow the sealed vial to equilibrate to room temperature before opening to prevent condensation. For long-term storage, consider under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Water Content (KF)	≤1.0%
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.