Description

Raloxifene Impurity 14 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 the active pharmaceutical ingredient (API) Raloxifene, a selective estrogen receptor modulator (SERM). It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and impurity profiling. The CAS number for this compound is 1190867-20-9.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Raloxifene API batches.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing of Raloxifene drug substances and finished dosage forms to meet pharmacopeial standards (USP, EP).
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used to monitor the formation of this specific impurity during forced degradation and long-term stability studies of Raloxifene products.
• Research & Development: Aids in synthetic chemistry research for studying the degradation pathways and metabolism of Raloxifene.

Basic Information

Item	Detail
Product Name	Raloxifene Impurity 14
CAS No.	1190867-20-9
Molecular Formula	C28H27NO4S
Molecular Weight	473.58 g/mol
Synonyms	Raloxifene Related Compound 14; Raloxifene EP Impurity 14; Raloxifene USP Impurity 14; 6-Hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl{4-[2-(1-piperidinyl)ethoxy]phenyl}methanone Impurity; Benzo[b]thiophen-3-ol, 6-hydroxy-2-(4-hydroxyphenyl)-, 3-[4-[2-(1-piperidinyl)ethoxy]benzoyl]-; Raloxifene Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Raloxifene Impurity 14 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, meeting the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity assay, related substance analysis, and spectroscopic identification (IR, MS, NMR). Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive (store away from light). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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