Description

Raloxifene Impurity CAS NO 175460-94-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Raloxifene hydrochloride, a selective estrogen receptor modulator (SERM) used in pharmaceutical formulations. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and contract research organizations (CROs) involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in Raloxifene API and finished dosage forms.
• Analytical Method Development and Validation: Used as a system suitability standard and for establishing detection/quantification limits in HPLC, UPLC, and LC-MS methods.
• Quality Control and Assurance (QC/QA): Essential for routine batch release testing of Raloxifene hydrochloride to ensure compliance with pharmacopeial standards (USP, EP, ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., 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).
• Academic and Clinical Research: Supports studies investigating the metabolism, pharmacokinetics, and safety profile of Raloxifene.

Basic Information

Item	Detail
Product Name	Raloxifene Impurity
CAS No.	175460-94-3
Molecular Formula	C28H27NO4S
Molecular Weight	473.58 g/mol
Synonyms	Raloxifene Related Compound; Raloxifene Impurity A (Potential); 6-Hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl{4-[2-(1-piperidinyl)ethoxy]phenyl}methanone; Methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]-; LY-156758 Impurity
EINECS	Contact for details

Quality Control

Every batch of Raloxifene Impurity CAS 175460-94-3 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Production is aligned with ICH Q7 and cGMP principles where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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