Description

6-tert-Butyldimethylsilyl-4A€-Hydroxy Raloxifene-D4 is a high-purity, deuterated derivative of a key pharmaceutical intermediate, specifically designed for use as an internal standard in advanced analytical applications. This compound is critical for ensuring the accuracy and reliability of quantitative mass spectrometry (MS) and liquid chromatography-mass spectrometry (LC-MS) analyses in drug development and quality control. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers requiring precise quantification of raloxifene and its metabolites.

Application

• Internal Standard for LC-MS/MS: Primary application as a stable, isotopically labeled internal standard for the precise quantification of raloxifene and related compounds in complex biological matrices (e.g., plasma, serum, tissue homogenates).
• Pharmaceutical R&D & Bioanalysis: Supports pharmacokinetic (PK), pharmacodynamic (PD), and metabolism studies during the development of Selective Estrogen Receptor Modulators (SERMs).
• Clinical Research & Diagnostics: Enables accurate therapeutic drug monitoring (TDM) and clinical study analysis for drugs targeting estrogen-related pathways.
• Method Development & Validation: Used to develop, optimize, and validate robust analytical methods in compliance with FDA, EMA, and ICH guidelines (e.g., ICH Q2(R1)).
• Reference Material for Impurity Profiling: Serves as a critical reference standard for identifying and quantifying process-related impurities and degradation products in active pharmaceutical ingredient (API) batches.
• Metabolite Identification Studies: Aids in the structural elucidation and tracking of metabolite formation in in vitro and in vivo studies.

Basic Information

Item	Details
Product Name	6-tert-Butyldimethylsilyl-4A€-Hydroxy Raloxifene-D4
CAS No.	1329611-25-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Raloxifene D4 TBDMS Derivative; 6-O-(tert-Butyldimethylsilyl)raloxifene-d4; Deuterated Raloxifene TBDMS Ether; Raloxifene-[d4] TBDMS; 4-[6-Hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl]-2-(4-tert-butyldimethylsilyloxyphenyl-d4)propiophenone; Isotopically Labeled Raloxifene Intermediate; Internal Standard for Raloxifene LC-MS
EINECS	Contact for details

Quality Control

Every batch of 6-tert-Butyldimethylsilyl-4A€-Hydroxy Raloxifene-D4 is manufactured and analyzed under strict quality systems to ensure it meets the exacting standards required for analytical reference materials. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure high chemical purity, isotopic enrichment, and structural identity. Certificates of Analysis (COA) detailing batch-specific results for purity, isotopic purity (D-enrichment), and identification are provided and are traceable to primary reference standards where applicable.

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. The product is light-sensitive and should be stored away from light. For long-term storage, consider storing desiccated under inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Meets ICH Q3C guidelines

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