Description

Azelastine CAS NO 58581-89-8 is a potent, selective histamine H1-receptor antagonist belonging to the phthalazinone class. This compound is of significant commercial and therapeutic importance as the active pharmaceutical ingredient (API) in ophthalmic and nasal solutions for the treatment of allergic conditions. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of anti-allergy medications. Its efficacy in managing symptoms like rhinorrhea, sneezing, and nasal congestion makes it a critical component in global allergy care.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription anti-allergy nasal sprays (e.g., for allergic rhinitis).
• Ophthalmic Solutions: Formulation into eye drops for the relief of allergic conjunctivitis, including itching and redness.
• Drug Development: Serves as a key reference standard and intermediate in preclinical and clinical research for new antihistamine therapies.
• Veterinary Medicine: Potential application in veterinary formulations for managing allergic reactions in animals.
• Combination Therapies: Used in fixed-dose combination products, often with corticosteroids like fluticasone, for enhanced efficacy.
• Analytical Standards: High-purity grades are used as certified reference materials (CRMs) in quality control laboratories for HPLC and spectroscopic analysis.

Basic Information

Product Name	Azelastine
CAS No.	58581-89-8
Molecular Formula	C22H24ClN3O
Molecular Weight	381.90 g/mol
Synonyms	4-[(4-Chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1(2H)-one; Azelastine Hydrochloride (salt form); Astelin (brand name); Optivar (brand name); Allergodil (brand name); Azeptin; CAS 79307-93-0 (Hydrochloride); Relestat
EINECS	261-320-0

Quality Control

Our Azelastine is manufactured and tested under strict quality management systems to meet the exacting standards of the pharmaceutical industry. We provide material compliant with major pharmacopoeial specifications, including USP and EP monographs. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, ensuring traceability and regulatory compliance for our global B2B clients.

Storage

Preserve in a tightly closed container, protected from light. Due to its hygroscopic (moisture-sensitive) nature, store under controlled room temperature (15-25°C) in a dry environment. For long-term stability, consider storage under an inert atmosphere.

Specification

Item	Specification
Appearance	White to almost white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm

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