Description

Raloxifene Impurity 19 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Raloxifene Hydrochloride. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in method development, validation, and routine batch testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Raloxifene HCl API and finished dosage forms.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Used in routine batch release testing to monitor impurity levels against established pharmacopeial or internal specifications.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of degradation products in Raloxifene formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer API batches.

Basic Information

Product Name	Raloxifene Impurity 19
CAS No.	937666-17-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Raloxifene Related Compound 19; Raloxifene EP Impurity 19; Raloxifene USP Impurity 19; 6-Hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl-4-[2-(1-piperidinyl)ethoxy]phenyl ketone impurity; Benzothiophene Impurity of Raloxifene
EINECS	Contact for details

Quality Control

Our Raloxifene Impurity 19 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (IR, NMR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material 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 powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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