Description

Ebastine Impurity F is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the antihistamine drug Ebastine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Ebastine Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities.
• Quality Assurance & Control (QA/QC): Serves as a benchmark in routine quality control testing to ensure Ebastine batches meet specified impurity limits per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity profiles and control strategies.
• Stability Studies: Employed in forced degradation and long-term stability studies of Ebastine to understand impurity formation pathways.
• Research & Development: Used in pharmaceutical R&D to study the synthesis, metabolism, and degradation chemistry of Ebastine and related compounds.

Basic Information

Product Name	Ebastine Impurity F
CAS No.	1429071-63-5
Molecular Formula	C32H39NO4
Molecular Weight	501.66 g/mol
Synonyms	Ebastine Related Compound F; Ebastine EP Impurity F; Ebastine USP Impurity F; 1-[4-(1,1-Dimethylethyl)phenyl]-4-[4-(diphenylmethoxy)piperidino]butan-1-one Impurity; 4-[4-(Benzhydryloxy)-1-piperidinyl]-1-(4-tert-butylphenyl)butan-1-one Impurity F
EINECS	Contact for details

Quality Control

Our Ebastine Impurity F is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized and confirmed against pharmacopeial standards where applicable. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile as determined by advanced techniques like HPLC and MS.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere to prevent degradation.

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 unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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