Description

Bepotastine is a potent, selective histamine H1-receptor antagonist with significant anti-allergic properties. This compound is of critical importance in the pharmaceutical industry for the development of advanced ophthalmic and systemic treatments for allergic conditions. It is primarily required by pharmaceutical manufacturers and research institutions focused on creating next-generation antihistamine medications, particularly for allergic conjunctivitis and rhinitis. Bepotastine CAS NO 125602-71-3 represents a high-value active pharmaceutical ingredient (API) for global therapeutic markets.

Application

• Primary Active Pharmaceutical Ingredient (API) in ophthalmic solutions for allergic conjunctivitis.
• Key component in oral tablet formulations for the treatment of allergic rhinitis and urticaria.
• Reference standard in analytical laboratories for quality control and method development.
• Intermediate in pharmaceutical research for synthesizing novel antihistamine derivatives.
• Raw material for clinical trial material (CTM) and investigational new drug (IND) applications.
• Used in preclinical studies to investigate mechanisms of allergic response and mast cell stabilization.

Basic Information

Product Name	Bepotastine
CAS No.	125602-71-3
Molecular Formula	C21H25ClN2O3
Molecular Weight	388.89 g/mol
Synonyms	Bepotastine Besilate; Bepotastine Besylate; TAU-284; (+)-4-[(S)-p-Chloro-α-(2-pyridyl)benzyloxy]-1-methylpiperidine; 4-[(S)-p-Chloro-α-(2-pyridyl)benzyloxy]-1-methylpiperidine; (S)-4-[4-Chloro-α-(2-pyridyl)benzyloxy]-1-methylpiperidine; Bepreve (USAN, Trade Name); TALION (Japanese Trade Name)
EINECS	Contact for details

Quality Control

Our Bepotastine is manufactured under strict quality management systems, ensuring it meets the stringent requirements for pharmaceutical actives. Each batch is tested against comprehensive specifications, including identity, purity, and impurity profiles, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to guarantee traceability and compliance.

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 must be kept under conditions that minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches 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

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