Description

Ebastine Impurity G is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the antihistamine drug Ebastine by enabling the accurate identification, quantification, and control of related substances. It is an essential material for analytical chemists, quality assurance professionals, and R&D scientists working in pharmaceutical companies, contract research organizations (CROs), and regulatory testing laboratories.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Ebastine active pharmaceutical ingredient (API) and finished drug products.
• Method Development and Validation: Critical for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-High-Performance Liquid Chromatography (UHPLC) assays.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity profiles and ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation of degradation products in Ebastine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the manufacturing process and product quality.
• Research and Development: Supports impurity profiling and route scouting during the synthesis and process optimization of Ebastine API.

Basic Information

Product Name	Ebastine Impurity G
CAS No.	1429071-65-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-(4-Bromophenyl)-4-hydroxy-1-(4-tert-butylphenyl)butan-1-one; Ebastine Related Compound G; Ebastine EP Impurity G; Ebastine USP Impurity G; Ebastine Process Impurity; Ebastine Degradant; (RS)-4-(4-Bromophenyl)-4-hydroxy-1-[4-(1,1-dimethylethyl)phenyl]butan-1-one
EINECS	Contact for details

Quality Control

Our Ebastine Impurity G is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Production can be aligned with current Good Manufacturing Practice (cGMP) principles for critical applications.

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 dry environment. For long-term storage, consider desiccants or inert atmosphere packaging to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.