Description

n-Desmethyl Tamoxifen Hydrochloride is a key pharmaceutical intermediate and metabolite of the widely used breast cancer therapeutic, Tamoxifen. Its primary value lies in its critical role in drug metabolism studies, analytical reference standards, and the research and development of novel selective estrogen receptor modulators (SERMs). This high-purity compound is essential for pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in oncology research, bioanalytical method development, and impurity profiling.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis and development of Tamoxifen and related SERM compounds.
• Reference Standard: Used as a certified reference material (CRM) for the quantification and identification of Tamoxifen metabolites in pharmacokinetic and bioequivalence studies.
• Metabolite Research: Essential for studying the metabolic pathways, efficacy, and safety profile of Tamoxifen in clinical and preclinical research.
• Impurity Standard: Serves as a specified impurity standard for quality control and regulatory compliance in Tamoxifen active pharmaceutical ingredient (API) manufacturing.
• Biochemical Research: Utilized in vitro studies to investigate estrogen receptor binding affinity and the mechanistic actions of Tamoxifen derivatives.
• Diagnostic Development: Potential use in the development of diagnostic assays and kits for therapeutic drug monitoring (TDM) in cancer patients.

Basic Information

Product Name	n-Desmethyl Tamoxifen Hydrochloride
CAS No.	15917-65-4
Molecular Formula	C25H28ClNO
Molecular Weight	393.95 g/mol
Synonyms	4-Hydroxytamoxifen N-Desmethyl Metabolite Hydrochloride; (Z)-4-(1-[4-(2-Dimethylaminoethoxy)phenyl]-2-phenyl-1-butenyl)phenol Hydrochloride; N-Desmethyltamoxifen HCl; Metabolite E Hydrochloride; Afimoxifene N-Desmethyl Metabolite Hydrochloride; Endoxifen Precursor Hydrochloride; trans-N-Desmethyl-4-Hydroxytamoxifen Hydrochloride
EINECS	Contact for details

Quality Control

Our n-Desmethyl Tamoxifen Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and stringent control of related substances and residual solvents. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with cGMP guidelines for pharmaceutical intermediates and reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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