Description

Raloxifene Hydrochloride is a selective estrogen receptor modulator (SERM) pharmaceutical compound. It is a critical active pharmaceutical ingredient (API) used in the development and manufacture of osteoporosis treatments. This high-purity compound is essential for pharmaceutical manufacturers and research institutions focused on women's health and metabolic bone disease. Its consistent quality and reliable supply are paramount for ensuring the safety and efficacy of final drug products.

Application

• Pharmaceutical API: Primary use as the active ingredient in finished dosage forms for the prevention and treatment of postmenopausal osteoporosis.
• Drug Formulation Development: Used in R&D for creating tablets, capsules, and other oral solid dosage forms.
• Clinical Research Material: Serves as a reference standard and raw material in preclinical and clinical trials for SERM-based therapies.
• Generic Drug Manufacturing: Key starting material for the production of generic versions of osteoporosis medications.
• Biochemical Research: Tool compound for studying estrogen receptor pathways, bone metabolism, and lipid biology in laboratory settings.
• Analytical Reference Standard: Used in quality control laboratories for HPLC, LC-MS, and other analytical method development and validation.

Basic Information

Product Name	Raloxifene Hydrochloride
CAS No.	82640-04-8
Molecular Formula	C28H27NO4S·HCl
Molecular Weight	510.04 g/mol
Synonyms	Raloxifene HCl; LY139481 hydrochloride; Keoxifene Hydrochloride; [6-Hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]methanone Hydrochloride; Evista (brand name API); 82640-04-8; Raloxifene HCL
EINECS	Contact for details

Quality Control

Our Raloxifene Hydrochloride is manufactured and tested under a strict quality management system. It is produced to meet exacting standards suitable for pharmaceutical applications, with typical purity exceeding 99.0%. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing identity, purity, impurity profile, and residual solvents. Our quality protocols are designed to support compliance with cGMP, ICH Q7 guidelines, and major pharmacopoeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 99.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single unknown impurity ≤ 0.2%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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