Description

4'-tert-Butyldimethylsilyl-6-Hydroxy Raloxifene-D4 is a deuterated derivative of a key raloxifene intermediate, specifically designed for use as an internal standard in analytical chemistry. This compound is critical for ensuring the accuracy and reliability of quantitative analyses in pharmaceutical research and development. It is primarily utilized by analytical chemists, quality control laboratories, and research institutions involved in the development and validation of bioanalytical methods for selective estrogen receptor modulators (SERMs).

Application

• Primary use as a stable isotope-labeled internal standard for the quantification of raloxifene and its metabolites in complex biological matrices via LC-MS/MS.
• Essential for pharmacokinetic and bioequivalence studies, enabling precise measurement of drug concentration in plasma, serum, and tissue samples.
• Supports method development and validation in accordance with FDA, EMA, and ICH guidelines for regulatory submissions.
• Used in doping control analysis to detect and confirm the presence of banned SERMs in athletic samples.
• Facilitates metabolite identification and profiling studies in drug metabolism and disposition research.
• Enables high-throughput screening and quality control in pharmaceutical manufacturing processes.

Basic Information

Product Name	4'-tert-Butyldimethylsilyl-6-Hydroxy Raloxifene-D4
CAS No.	1189422-34-1
Molecular Formula	C32H37D4NO3Si
Molecular Weight	515.8 g/mol
Synonyms	6-Hydroxy-4'-(tert-butyldimethylsilyl)raloxifene-d4; 4'-(tert-Butyldimethylsilyl)-6-hydroxyraloxifene-d4; Raloxifene TBDMS Ether-d4; Raloxifene Derivative-d4; 2-(4-Hydroxyphenyl)-3-[4-[2-(1-piperidinyl)ethoxy]benzoyl]-6-hydroxy-4'-(tert-butyldimethylsilyl)benzothiophene-d4; LY156758 derivative-d4; Keoxifene intermediate-d4; Internal Standard for Raloxifene-d4
EINECS	Contact for details

Quality Control

Our 4'-tert-Butyldimethylsilyl-6-Hydroxy Raloxifene-D4 is manufactured under strict quality systems to ensure the high chemical purity and isotopic enrichment required for analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity by HPLC, isotopic purity (D-enrichment), and identity confirmation. We adhere to relevant ICH Q7 and GMP guidelines for the production of reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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