Description

Raloxifene 6'-Glucuronide is a major, pharmacologically relevant metabolite of the selective estrogen receptor modulator (SERM) Raloxifene. 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 analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in the development and quality control of SERM-based therapies, where it serves as a certified reference standard.

Application

• Pharmaceutical Reference Standard: Used as a high-purity certified standard for the quantitative and qualitative analysis of Raloxifene and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic pathways, bioavailability, and clearance mechanisms of Raloxifene in preclinical and clinical research.
• Bioanalytical Method Development: Serves as a critical component in developing and validating robust HPLC, LC-MS, or LC-MS/MS methods for therapeutic drug monitoring and pharmacokinetic assays.
• Impurity Profiling and Characterization: Employed to identify, quantify, and qualify potential glucuronidated impurities or degradants in Raloxifene drug substance and finished product formulations.
• Clinical Research Support: Used in studies to understand the inter-patient variability in Raloxifene metabolism and its correlation with efficacy or safety profiles.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive understanding of a drug's metabolic fate.

Basic Information

Product Name	Raloxifene 6'-Glucuronide
CAS No.	174264-50-7
Molecular Formula	C33H35NO11S
Molecular Weight	653.70 g/mol
Synonyms	Raloxifene 6'-β-D-Glucuronide; 6'-Glucuronyl Raloxifene; Raloxifene Glucuronide (6'-isomer); (6-Hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl)(4-(2-(1-piperidinyl)ethoxy)phenyl)methanone 6'-β-D-Glucopyranosiduronic Acid; LY353381 6'-Glucuronide; Keoxifene 6'-Glucuronide
EINECS	Contact for details

Quality Control

Every batch of Raloxifene 6'-Glucuronide is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and stability testing to ensure compliance with the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA), detailing results from HPLC, LC-MS, NMR, and other relevant analytical techniques, is provided with each shipment to guarantee traceability and reliability for your critical research applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. Keep the container tightly sealed in a dry place after each use.

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)	≤2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Heavy Metals	<20 ppm

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