Description

Ebastine Ep Impurity E is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the antihistamine drug Ebastine by serving as a key marker for impurity profiling and analytical method validation. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing. The product is supplied with comprehensive analytical data to support regulatory filings and stringent quality standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Ebastine Ep Impurity E in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods to monitor impurities during API synthesis.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure drug substance and drug product purity complies with pharmacopeial limits (e.g., ICH Q3A/B guidelines).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed as an analytical marker to track the formation of degradation products in forced degradation and long-term stability studies of Ebastine.
• Research & Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this specific impurity during synthesis.

Basic Information

Product Name	Ebastine Ep Impurity E
CAS No.	1312211-93-0
Molecular Formula	C32H39NO4
Molecular Weight	501.66 g/mol
Synonyms	Ebastine Impurity E; Ebastine Related Compound E; 1-[4-(1,1-Dimethylethyl)phenyl]-4-[4-(diphenylmethoxy)piperidino]butan-1-one Impurity; 4-[4-(Diphenylmethoxy)-1-piperidinyl]-1-[4-(1,1-dimethylethyl)phenyl]-1-butanone Impurity E; Ebastine EP Impurity E; Ebastine Process Impurity; Ebastine Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Ebastine Ep Impurity E is manufactured and controlled under a strict quality management system. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR 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 ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or 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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
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.