Description

Raloxifene Impurity 1 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Raloxifene, a selective estrogen receptor modulator (SERM). It is an essential material for pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in drug development, regulatory compliance, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Raloxifene Impurity 1 in Raloxifene API and finished dosage forms.
• Method Development and Validation: Crucial for developing and validating robust analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch analysis to monitor impurity profiles and ensure drug substance and product specifications are met.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions and throughout shelf-life studies.
• Research and Development: Facilitates process chemistry optimization by identifying and controlling impurity formation during Raloxifene synthesis.

Basic Information

Product Name	Raloxifene Impurity 1
CAS No.	84449-85-4
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 A; Raloxifene EP Impurity A; Raloxifene USP Impurity; Benzothiophene Impurity of Raloxifene; (6-Hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl)(4-(2-(piperidin-1-yl)ethoxy)phenyl)methanone; EVISTA Impurity
EINECS	Contact for details

Quality Control

Every batch of Raloxifene Impurity 1 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

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

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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%
Heavy Metals	≤ 20 ppm

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