Description

Raloxifene Impurity 18 (CAS NO 414861-41-9) is a designated impurity standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Raloxifene. This compound is essential for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of Raloxifene-based drug products. It is primarily used by professionals in pharmaceutical development, quality assurance, and regulatory compliance for method validation, stability studies, and impurity identification.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Raloxifene Impurity 18 in API and finished drug products.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to monitor batch-to-batch consistency and impurity levels.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research and Development: Used in synthetic chemistry research to study degradation pathways and to develop purification processes for Raloxifene.

Basic Information

Product Name	Raloxifene Impurity 18
CAS No.	414861-41-9
Molecular Formula	C28H27NO4S
Molecular Weight	473.58 g/mol
Synonyms	6-Hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl{4-[2-(1-piperidinyl)ethoxy]phenyl}methanone; Raloxifene Related Compound 18; Raloxifene EP Impurity G; Raloxifene USP Related Compound G; (6-Hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl)(4-(2-(piperidin-1-yl)ethoxy)phenyl)methanone; Raloxifene Desmethyl Impurity; Raloxifene Process Impurity
EINECS	Contact for details

Quality Control

Our Raloxifene Impurity 18 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and accurate identification. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), and related substances. The material is suitable for use as a pharmaceutical reference standard in compliance with current Good Manufacturing Practice (cGMP) principles and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-30°C (59-86°F). This material 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 structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.2%

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