Description

Ospemifene 4'-Hydroxy Impurity is a high-purity reference standard and pharmaceutical impurity used in the development and quality control of the active pharmaceutical ingredient (API) Ospemifene. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products by enabling accurate identification and quantification of this specific degradant. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on women's health therapeutics.

Application

• Primary use as a certified reference standard for analytical method development and validation (HPLC, LC-MS).
• Critical pharmaceutical impurity for monitoring and controlling the quality of Ospemifene API during manufacturing.
• Essential component in stability studies to profile degradation pathways of Ospemifene formulations.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity limits and specifications.
• Valuable research chemical for studying the metabolism and pharmacokinetics of Ospemifene.
• Serves as a building block or intermediate in advanced organic synthesis for related compounds.

Basic Information

Item	Details
Product Name	Ospemifene 4'-Hydroxy Impurity
CAS No.	341525-22-2
Molecular Formula	C24H23NO3
Molecular Weight	373.45 g/mol
Synonyms	4'-Hydroxyospemifene; 2-[4-[(1Z)-4-Chloro-1,2-diphenyl-1-buten-1-yl]phenoxy]ethanol; FC-1271a; Ospemifene Impurity A; Ospemifene Related Compound A; Dehydroxyospemifene; Z-4-Hydroxyospemifene
EINECS	Contact for details

Quality Control

Every batch of our Ospemifene 4'-Hydroxy Impurity is manufactured under strict quality management systems and undergoes comprehensive analytical testing. We provide full traceability and Certificates of Analysis (COA) that detail purity, identity, and impurity profiles, ensuring compliance with ICH guidelines for pharmaceutical impurities. Our standards are suitable for use in GMP/GLP environments.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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