Description

(S)-Azelastine CAS NO 143228-85-7 is the single, pharmacologically active enantiomer of the well-known antihistaminic and mast cell-stabilizing agent. This high-purity chiral intermediate is critical for the development of next-generation, enantiomerically pure pharmaceutical formulations with enhanced efficacy and reduced side-effect profiles. It is primarily required by advanced pharmaceutical R&D laboratories and manufacturers specializing in ophthalmic and intranasal anti-allergy treatments, as well as novel respiratory therapeutics.

Application

• Active Pharmaceutical Ingredient (API) Synthesis: Key chiral building block for the production of enantiopure azelastine hydrochloride, used in prescription anti-allergy medications.
• Ophthalmic Solutions: Manufacture of advanced eye drops for the treatment of allergic conjunctivitis, leveraging the superior activity of the (S)-enantiomer.
• Nasal Sprays: Production of intranasal antihistamine sprays for seasonal and perennial allergic rhinitis.
• Pharmaceutical R&D: Reference standard and starting material for preclinical and clinical studies of new enantioselective drug candidates targeting histamine H1 receptors.
• Process Chemistry & Optimization: Used in developing and scaling up asymmetric synthesis routes for cost-effective manufacturing of chiral drugs.
• Analytical Standard: Serves as a high-purity standard for HPLC, LC-MS, and chiral assay method development and validation in quality control laboratories.

Basic Information

Product Name	(S)-Azelastine
CAS No.	143228-85-7
Molecular Formula	C22H24ClN3O
Molecular Weight	381.90 g/mol
Synonyms	(S)-Azelastine; (-)-Azelastine; (S)-4-[(4-Chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1(2H)-one; (S)-4-(p-Chlorobenzyl)-2-(hexahydro-1-methyl-1H-azepin-4-yl)-1(2H)-phthalazinone; Levocabastine Impurity F (Azelastine Related Compound); UNII-4VB9F3D5K2; Azelastine S-Enantiomer; (S)-Azelastine Base
EINECS	Contact for details

Quality Control

Our (S)-Azelastine is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including chiral HPLC to confirm enantiomeric excess (typically >99.0%) and standard pharmacopeial identification tests. We provide full traceability and Certificates of Analysis (COA) are available for every shipment, detailing purity, related substances, residual solvents, and other critical parameters to ensure compliance with your R&D or cGMP manufacturing requirements.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere (e.g., nitrogen or argon) after opening to prevent degradation. Keep the container tightly sealed in a desiccated environment.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.5%
Enantiomeric Purity (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%
Heavy Metals	≤ 20 ppm

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