Description

Hydroxy Ebastine is a key pharmaceutical intermediate and the primary active metabolite of the antihistamine drug Ebastine. This compound is critical for the development and quality control of advanced antihistamine formulations, ensuring therapeutic efficacy and safety. It is essential for pharmaceutical manufacturers and research institutions focused on respiratory and allergic disorder treatments, serving as a reference standard and a building block for next-generation therapies.

Application

• Pharmaceutical Intermediate: Primary use as a critical building block in the synthesis of the antihistamine Ebastine and its related analogs.
• Reference Standard: Serves as an analytical standard for quality control and assay development in pharmaceutical manufacturing.
• Metabolite Studies: Used in pharmacokinetic and pharmacodynamic research to study the metabolism and activity profile of Ebastine.
• Active Pharmaceutical Ingredient (API) Development: A key starting material for the research and development of new antihistamine drugs.
• Impurity Profiling: Employed to identify, quantify, and control related substances in Ebastine drug substance and finished dosage forms.
• Clinical Research: Utilized in bioanalytical method development for patient sample analysis during clinical trials.

Basic Information

Product Name	Hydroxy Ebastine
CAS No.	210686-41-2
Molecular Formula	C32H39NO3
Molecular Weight	485.66 g/mol
Synonyms	Carebastine; 4'-Hydroxyebastine; 1-[4-(1,1-Dimethylethyl)phenyl]-4-[4-(diphenylmethoxy)-1-piperidinyl]-1-butanol; (+-)-1-(p-tert-Butylphenyl)-4-[4-(α-phenylbenzyloxy)piperidino]butan-1-ol; Ebastine metabolite; BNF-66
EINECS	Contact for details

Quality Control

Our Hydroxy Ebastine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and identification by spectroscopic methods, to ensure it meets stringent specifications for pharmaceutical use. Certificates of Analysis (COA) with full traceability are provided to guarantee supply reliability and batch-to-batch consistency for your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Keep the container tightly sealed in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single impurity ≤0.5%
Residual Solvents (GC)	Meets ICH guidelines
Loss on Drying	≤0.5%

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