Description

Raloxifene Ep Impurity CAS NO 1700655-64-6 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Raloxifene, a selective estrogen receptor modulator (SERM). This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and control during manufacturing. It is an essential material for analytical laboratories, regulatory affairs, and R&D departments within the global pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Raloxifene Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Raloxifene.
• Quality Control and Batch Release: Employed in routine QC testing to ensure Raloxifene batches meet stringent pharmacopeial (e.g., USP, EP) and internal specification limits for impurities.
• Regulatory Compliance and Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate understanding and control of the drug substance's impurity profile.
• Stability Studies: Used to monitor the formation of this impurity over time under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Research and Development: Facilitates process chemistry research to understand impurity formation pathways and optimize synthesis routes for purer Raloxifene API.

Basic Information

Item	Detail
Product Name	Raloxifene Ep Impurity
CAS No.	1700655-64-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Raloxifene EP Impurity; Raloxifene Related Compound; Raloxifene Specified Impurity; (6-Hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl)(4-(2-(1-piperidinyl)ethoxy)phenyl)methanone Impurity; Raloxifene Process Impurity; Raloxifene Degradant; Keoxifene Impurity
EINECS	Contact for details

Quality Control

Our Raloxifene Ep Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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