Description

(R)-Azelastine is the single enantiomer of the potent, long-acting H1-receptor antagonist and mast cell stabilizer, Azelastine. This specific stereoisomer is of significant interest in advanced pharmaceutical research and development due to its potential for enhanced pharmacological activity and reduced side-effect profiles compared to the racemic mixture. It is a critical chiral intermediate and reference standard for the development of next-generation antihistamine and anti-allergy therapeutics. Key industries requiring this high-purity enantiomer include pharmaceutical R&D, contract manufacturing organizations (CMOs), and analytical laboratories focused on chiral separation and drug metabolism studies.

Application

• Primary chiral building block for the synthesis of novel enantiomerically pure antihistamine drugs.
• Pharmaceutical reference standard for analytical method development, validation, and quality control (HPLC, Chiral Chromatography).
• Key intermediate in preclinical and clinical research for allergic rhinitis and conjunctivitis treatments.
• Used in stereoselective metabolism and pharmacokinetics (PK/PD) studies.
• Critical material for impurity profiling and identification in racemic azelastine API manufacturing.
• Research chemical for investigating the structure-activity relationship (SAR) of histamine H1-receptor antagonists.

Basic Information

Product Name	(R)-Azelastine
CAS No.	143228-84-6
Molecular Formula	C22H24ClN3O
Molecular Weight	381.90 g/mol
Synonyms	(R)-(-)-Azelastine; (R)-Azelastine; (-)-Azelastine; (R)-4-[(4-Chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1(2H)-one; (R)-4-(p-Chlorobenzyl)-2-(hexahydro-1-methyl-1H-azepin-4-yl)-1(2H)-phthalazinone; Azelastine R-enantiomer; UNII-1H8T5Y5H5P
EINECS	Contact for details

Quality Control

Our (R)-Azelastine is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including chiral purity determination by HPLC, to ensure it meets stringent specifications for pharmaceutical research. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and enantiomeric excess. We support compliance with cGMP and ICH Q7 guidelines for active pharmaceutical ingredients (APIs) and advanced intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The compound is light-sensitive and should be handled under appropriate conditions to maintain stability.

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%
Enantiomeric Excess (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Loss on Drying	≤ 0.5%
Residue on Ignition	≤ 0.1%

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