Description

Raloxifene Impurity 21 is a designated reference standard used in the analytical profiling and quality control of Raloxifene hydrochloride, a selective estrogen receptor modulator (SERM). This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by identifying and quantifying process-related impurities. It is primarily utilized by professionals in pharmaceutical development, quality assurance (QA), and regulatory affairs who require high-purity chemical reference materials for method validation and compliance documentation.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of Raloxifene-related impurities in API batches.
• Analytical Method Development and Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits.
• Quality Control (QC) and Quality Assurance (QA): Essential for routine testing in pharmaceutical QC laboratories to monitor impurity levels against 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.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions.
• Research and Development: Used in synthetic chemistry R&D to understand and optimize the Raloxifene manufacturing process.

Basic Information

Product Name	Raloxifene Impurity 21
CAS No.	938140-30-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Raloxifene Related Compound 21; Raloxifene Hydrochloride Impurity 21; 6-Hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl-4-[2-(1-piperidinyl)ethoxy]phenyl methanone impurity; Benzothiophene Impurity of Raloxifene; Raloxifene Process Impurity; SERM Impurity Standard; EVISTA® Impurity Reference
EINECS	Contact for details

Quality Control

Our Raloxifene Impurity 21 is manufactured and handled under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization by spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to primary standards. Our quality commitment aligns with cGMP principles for pharmaceutical impurities.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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