Description

Azelastine Hydrochloride CAS NO 79307-93-0 is a potent, selective histamine H1-receptor antagonist and mast cell stabilizer. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of modern ophthalmic and intranasal anti-allergic medications. It is primarily required by pharmaceutical manufacturers and R&D facilities developing treatments for allergic conjunctivitis and allergic rhinitis.

Application

• Primary Active Pharmaceutical Ingredient (API) in prescription ophthalmic solutions for allergic conjunctivitis.
• Key component in intranasal sprays for the treatment of seasonal and perennial allergic rhinitis.
• Used in pharmaceutical research and development for novel anti-allergy formulations.
• Reference standard in analytical laboratories for quality control and method validation.
• Intermediate in the synthesis of more complex pharmaceutical compounds.
• Investigational material for preclinical and clinical studies targeting histamine-mediated pathways.

Basic Information

Product Name	Azelastine Hydrochloride
CAS No.	79307-93-0
Molecular Formula	C22H24ClN3O • HCl
Molecular Weight	418.36 g/mol
Synonyms	4-[(4-Chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1-one hydrochloride; Azelastine HCl; Astelin (brand name related); Optivar (brand name related); Allergodil (brand name related); Afluon; WAL 801
EINECS	Contact for details

Quality Control

Our Azelastine Hydrochloride is manufactured under strict quality management systems. It undergoes rigorous analytical testing to meet or exceed relevant pharmacopeial standards, including identification, purity, and impurity profile assessments. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed after opening to protect from moisture.

Specification

Item	Specification
Appearance	White to almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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