Description

Elacestrant Dihydrochloride is a high-purity, non-steroidal selective estrogen receptor degrader (SERD) active pharmaceutical ingredient (API). This compound is critical for the development and manufacturing of targeted oncology therapeutics, specifically for the treatment of hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer. It is primarily utilized by pharmaceutical R&D departments, contract manufacturing organizations (CMOs), and academic research institutions focused on next-generation endocrine therapies. The product is supplied under stringent quality controls to ensure batch-to-batch consistency for preclinical and clinical applications.

Application

• Pharmaceutical API: Serves as the active ingredient in the formulation of finished dosage forms for clinical and commercial use.
• Oncology Research: Used as a reference standard and investigational compound in studies targeting estrogen receptor (ER) signaling pathways.
• Drug Development: Essential for preclinical pharmacokinetic, pharmacodynamic, and toxicology studies.
• Analytical Standard: Employed in HPLC, LC-MS, and NMR methods for quality control and assay development.
• Combinatorial Therapy Research: Investigated in combination with other agents like CDK4/6 inhibitors for enhanced therapeutic efficacy.

Basic Information

Product Name	Elacestrant Dihydrochloride
CAS No.	1349723-93-8
Molecular Formula	C26H26F5N3O3 • 2HCl
Molecular Weight	610.42 g/mol (free base: 523.50 g/mol)
Synonyms	RAD1901 dihydrochloride; Elacestrant HCl; 1-(4-((2-(4-fluoro-2,6-difluorophenoxy)ethyl)(propyl)amino)-2,6-difluorophenyl)-1,5,6,7-tetrahydro-4H-indazol-4-one dihydrochloride; (S)-Elacestrant dihydrochloride; RAD1901-2HCl; SC 142; Estrogen Receptor Degrader RAD1901 dihydrochloride
EINECS	Contact for details

Quality Control

Our Elacestrant Dihydrochloride is manufactured under a quality management system compliant with cGMP guidelines for API production. Each batch is subjected to rigorous analytical testing, including HPLC for purity and assay, chiral purity determination, and comprehensive identification and impurity profiling to ensure it meets stringent pharmaceutical-grade specifications. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic nature, the container must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	≥98.0% (on anhydrous basis)
Chiral Purity (HPLC)	≥99.0%
Water Content (KF)	≤2.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Individual impurity ≤0.5%; Total impurities ≤2.0%

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