Description

(R)-Azelastine n-Oxide (Mixture Of Diastereomers) is a key chiral intermediate and metabolite in the synthesis and study of the potent antihistamine Azelastine. This compound is critical for pharmaceutical research and development, particularly in the investigation of drug metabolism, pharmacokinetics, and the production of enantiomerically pure active pharmaceutical ingredients (APIs). It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in advanced respiratory and ophthalmic drug development.

Application

• Pharmaceutical Intermediate: Serves as a crucial building block in the synthesis of the antihistamine drug Azelastine HCl.
• Metabolite Reference Standard: Used as an analytical standard in bioanalytical studies to identify and quantify drug metabolites in pharmacokinetic and ADME (Absorption, Distribution, Metabolism, and Excretion) research.
• Chiral Synthesis: Employed in asymmetric synthesis and process development for creating enantiomerically pure pharmaceutical compounds.
• Quality Control & Impurity Profiling: Acts as a known impurity or reference compound for HPLC/LC-MS method development and validation in pharmaceutical quality control laboratories.
• Pharmacological Research: Used in *in vitro* and *in vivo* studies to understand the structure-activity relationship (SAR) and metabolic pathways of Azelastine and related compounds.
• Regulatory Submission Support: Provides essential data and reference materials for regulatory filings (e.g., with FDA, EMA) for new drug applications (NDAs) or generic drug approvals.

Basic Information

Product Name	(R)-Azelastine n-Oxide (Mixture Of Diastereomers)
CAS No.	1346617-18-2
Molecular Formula	C22H24ClN3O2
Molecular Weight	397.90 g/mol
Synonyms	4-[(4R)-4-Chlorophenylmethyl]-2-(1-methylazepan-4-yl)phthalazin-1-one N-Oxide; (R)-Azelastine N-Oxide; Azelastine Impurity O; Azelastine Related Compound O; Azelastine N-Oxide Diastereomer; 1(2H)-Phthalazinone, 4-[(4-chlorophenyl)methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, 1-oxide, (4R)-; UNII-6K3F8H59QO
EINECS	Contact for details

Quality Control

Our (R)-Azelastine n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral purity determination, to ensure it meets the high standards required for pharmaceutical research and development. A detailed Certificate of Analysis (COA) providing HPLC purity, chiral purity, and identification data (IR, NMR, MS) is supplied with every shipment. We support compliance with ICH Q7 and cGMP guidelines for advanced intermediates.

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 product is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0% (R-isomer)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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