Description

Bexarotene Impurity 8 is a designated impurity of the active pharmaceutical ingredient Bexarotene, a retinoid X receptor (RXR) agonist used in chemotherapy. This compound is critical for pharmaceutical research and development, specifically for analytical method development, stability studies, and quality control (QC) testing of Bexarotene drug substances and products. It is an essential reference standard for laboratories in the pharmaceutical and biotechnology sectors ensuring product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Bexarotene Impurity 8 in drug substances and finished products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurities in Bexarotene batches.
• Stability and Forced Degradation Studies: Used to identify and track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Assurance: Serves as an in-house control standard to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines on impurities.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity profiles and justify specification limits.
• Research on Degradation Pathways: Utilized in academic and industrial research to understand the chemical degradation mechanisms of Bexarotene.

Basic Information

Product Name	Bexarotene Impurity 8
CAS No.	29641-87-0
Molecular Formula	C24H28O2
Molecular Weight	348.48 g/mol
Synonyms	4-[1-(5,6,7,8-Tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl)ethenyl]benzoic Acid; LG 100754 Impurity; Targretin Impurity; (E)-4-[1-(5,6,7,8-Tetrahydro-3,5,5,8,8-pentamethyl-2-naphthyl)vinyl]benzoic Acid; Bexarotene Related Compound 8; Bexarotene EP Impurity B; Bexarotene USP Related Compound
EINECS	Contact for details

Quality Control

Every batch of Bexarotene Impurity 8 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and relevant pharmacopeial guidelines (USP, EP).

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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