Description

Azelastine n-Oxide is a key pharmaceutical intermediate and metabolite of the widely used antihistamine Azelastine. This compound is of significant importance for research and development in the pharmaceutical industry, particularly in the study of drug metabolism, pharmacokinetics, and the synthesis of novel therapeutic agents. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in the development and quality control of respiratory and ophthalmic medications.

Application

• Pharmaceutical Intermediate: Critical for the synthesis and development of Azelastine hydrochloride and related antihistamine APIs.
• Metabolite Reference Standard: Used as an analytical standard in bioanalytical studies to understand the metabolic pathway and pharmacokinetics of Azelastine.
• Impurity Standard: Essential for quality control laboratories to identify, quantify, and control this specific impurity in Azelastine drug substances and finished products.
• Research Chemical: Employed in preclinical and clinical research to investigate the pharmacological activity and safety profile of Azelastine metabolites.
• Process Development: Used in the optimization of manufacturing processes for Azelastine to ensure yield, purity, and regulatory compliance.

Basic Information

Product Name	Azelastine n-Oxide
CAS No.	640279-88-5
Molecular Formula	C22H24ClN3O2
Molecular Weight	397.90 g/mol
Synonyms	4-[(4-Chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1(2H)-one 1-Oxide; Azelastine N-Oxide; Azelastine Impurity F (EP); Azelastine Related Compound F; Azelastine Metabolite; 1(2H)-Phthalazinone, 4-[(4-chlorophenyl)methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, 1-oxide
EINECS	Contact for details

Quality Control

Our Azelastine n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via IR and NMR, to ensure it meets the stringent requirements for pharmaceutical reference standards and intermediates. Certificates of Analysis (COA) with detailed chromatographic data are provided for every shipment, supporting compliance with ICH guidelines and pharmacopeial standards (EP/JP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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