Description

n-Desmethyl-4-Hydroxy Tamoxifen-D5 (1:1 E/Z Mixture) is a deuterated isotopologue of a key active metabolite of the selective estrogen receptor modulator (SERM) tamoxifen. This compound is of critical importance for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is an essential tool for pharmaceutical R&D laboratories, clinical research organizations, and contract research organizations (CROs) focused on oncology drug development and therapeutic drug monitoring.

Application

• Internal Standard for LC-MS/MS: Primary application as a high-purity, stable isotope-labeled internal standard for the precise quantification of tamoxifen and its metabolites in complex biological matrices like plasma, serum, and tissue homogenates.
• Pharmacokinetic (PK) Studies: Enables accurate determination of drug concentration-time profiles for tamoxifen and its active metabolites, supporting bioavailability and bioequivalence studies.
• Metabolite Profiling & Identification: Used in drug metabolism and pharmacokinetics (DMPK) research to study the metabolic pathways and clearance mechanisms of tamoxifen.
• Therapeutic Drug Monitoring (TDM): Facilitates the development and validation of robust clinical assays to monitor tamoxifen levels in patients, aiding in personalized medicine and dose optimization.
• Biomarker Research: Supports research into biomarkers related to tamoxifen efficacy and resistance in breast cancer treatment.
• Reference Standard: Serves as a certified reference material for method development, validation, and quality control in analytical laboratories.

Basic Information

Product Name	n-Desmethyl-4-Hydroxy Tamoxifen-D5 (1:1 E/Z Mixture)
CAS No.	1584173-54-5
Molecular Formula	C25H24D5NO2
Molecular Weight	~ 382.56 g/mol
Synonyms	4-Hydroxydesmethyltamoxifen-D5; Endoxifen-D5; (Z)-4-Hydroxy-N-desmethyltamoxifen-D5; 1-[4-[2-(Dimethylamino)ethoxy]phenyl]-1-(4-hydroxyphenyl)-2-phenylbut-1-ene-D5; 4-OH-N-desmethyltamoxifen-D5; 4-Hydroxy-N-desmethyltamoxifen-D5; Endoxifen-d5 (mixture of E/Z isomers)
EINECS	Contact for details

Quality Control

Our n-Desmethyl-4-Hydroxy Tamoxifen-D5 is manufactured under strict quality systems to ensure it meets the exacting requirements for analytical reference standards. Each batch is characterized using advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and mass spectrometry, to confirm identity, isomeric ratio, chemical purity, and isotopic enrichment. A comprehensive Certificate of Analysis (COA) is provided, detailing all critical quality attributes. We support compliance with GMP/GLP guidelines for use in regulated studies.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isomeric Ratio (E/Z by HPLC)	~ 1:1
Isotopic Enrichment (D-content by MS)	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Meets ICH guidelines

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