Description

n-Desmethyl-4Hydroxy Tamoxifen is a key active metabolite and reference standard of the widely used selective estrogen receptor modulator (SERM), Tamoxifen. This compound is of critical importance for pharmaceutical research, development, and quality control processes, providing a definitive benchmark for analytical studies. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic laboratories engaged in oncology research, drug metabolism studies, and bioanalytical method validation.

Application

• Pharmaceutical Reference Standard: Serves as a primary chemical reference material for the identification and quantification of Tamoxifen metabolites in drug substance and finished product analysis.
• Bioanalytical Research: Essential for developing and validating HPLC, LC-MS, and other analytical methods to study Tamoxifen pharmacokinetics and pharmacodynamics.
• Metabolite Studies: Used in in vitro and in vivo research to understand the metabolic pathway, activity, and clearance of Tamoxifen.
• Quality Control (QC) Testing: Employed in pharmaceutical QC laboratories to ensure the purity, potency, and consistency of Tamoxifen-based drug products.
• Clinical Research: Supports studies investigating patient response variability, therapeutic drug monitoring, and the mechanism of action of Tamoxifen therapy.

Basic Information

Product Name	n-Desmethyl-4Hydroxy Tamoxifen
CAS No.	170171-12-7
Molecular Formula	C25H27NO2
Molecular Weight	373.49 g/mol
Synonyms	4-Hydroxytamoxifen N-Desmethyl Metabolite; (Z)-4-Hydroxy-N-desmethyltamoxifen; Endoxifen Impurity; Afimoxifene Impurity B; FC-1271a; Z-4-Hydroxy-N-desmethyltamoxifen; 1-[4-[2-(Dimethylamino)ethoxy]phenyl]-1-(4-hydroxyphenyl)-2-phenylbut-1-ene
EINECS	Contact for details

Quality Control

Our n-Desmethyl-4Hydroxy Tamoxifen is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 2.0%
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.