Description

(Z)-4-Hydroxy Tamoxifen-D5 is a deuterated internal standard of the active metabolite of the selective estrogen receptor modulator (SERM) Tamoxifen. This high-purity reference material is critical for ensuring the accuracy and reliability of quantitative bioanalytical methods, particularly in pharmacokinetic and metabolism studies. It is an essential tool for pharmaceutical R&D laboratories, clinical research organizations, and regulatory bodies requiring precise and reproducible analytical data.

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of 4-Hydroxy Tamoxifen and related metabolites in biological matrices (plasma, serum, tissue).
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Drug Metabolism Research: Used to study the metabolic pathways and biotransformation of Tamoxifen, aiding in the understanding of its efficacy and side-effect profile.
• Clinical Trial Support: Provides method validation and sample analysis support for clinical trials involving Tamoxifen therapy, ensuring data integrity for regulatory submissions.
• Forensic and Doping Control Analysis: Applied in specialized testing laboratories for the accurate detection and quantification of Tamoxifen and its metabolites.
• Quality Control in Pharmaceutical Manufacturing: Can be utilized in in-process control and final product testing for Tamoxifen-based formulations.

Basic Information

Product Name	(Z)-4-Hydroxy Tamoxifen-D5
CAS No.	164365-20-2
Molecular Formula	C26H24D5NO2
Molecular Weight	~377.55 g/mol
Synonyms	4-Hydroxy Tamoxifen-d5; (Z)-4-Hydroxytamoxifen-d5; (Z)-1-[4-[2-(Dimethylamino)ethoxy]phenyl]-1,2-diphenyl-1-buten-4-ol-d5; trans-4-Hydroxy Tamoxifen-d5; NSC 108073-d5; Metabolite E-d5; Afimoxifene-d5; Endoxifen-d5 (Note: Endoxifen typically refers to the (Z)-isomer)
EINECS	Contact for details

Quality Control

Our (Z)-4-Hydroxy Tamoxifen-D5 is manufactured under strict quality systems to ensure the highest standards of purity and isotopic enrichment required for analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, chemical and isotopic purity, and residual solvents. We support compliance with cGMP, ICH Q7, and ISO 9001 standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below under an inert atmosphere for long-term stability. Allow the sealed vial to equilibrate to room temperature before opening to prevent moisture condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0% (Chemical Purity)
Isotopic Purity (MS)	≥98.0 atom % D
Isomeric Purity (HPLC)	≥99.0% (Z)-isomer
Water Content (KF)	≤0.5%
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.