Description

Bepotastine Besilate is a potent, selective histamine H1-receptor antagonist. This active pharmaceutical ingredient (API) is valued for its efficacy in managing allergic conditions with a favorable safety profile. It is primarily required by pharmaceutical manufacturers for the formulation of ophthalmic solutions and oral tablets targeting allergic conjunctivitis and other hypersensitivity disorders.

Application

• Primary API in the manufacture of ophthalmic solutions for allergic conjunctivitis.
• Key ingredient in oral tablet formulations for systemic allergy relief.
• Used in clinical research and development of new anti-allergic therapeutics.
• Reference standard in analytical laboratories for quality control and method validation.
• Potential component in combination drug therapies for enhanced efficacy.
• Raw material for generic pharmaceutical production following patent expiry.

Basic Information

Product Name	Bepotastine Besilate
CAS No.	190730-42-8
Molecular Formula	C21H25ClN2O3 · C7H6O3S
Molecular Weight	547.06 g/mol
Synonyms	Bepotastine Besylate; Bepotastine Benzenesulfonate; (S)-4-[4-[(4-Chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric Acid Monobenzenesulfonate; TAU-284; Bepreve (Brand Name Ophthalmic Solution); TALION (Brand Name Oral Tablet); UCB-21314
EINECS	Contact for details

Quality Control

Our Bepotastine Besilate is manufactured under strict quality management systems. Each batch is tested to meet high-purity pharmacopeial standards, with comprehensive analytical profiles covering identity, assay, and impurity limits. Certificates of Analysis (COA) are provided, confirming compliance with relevant specifications for pharmaceutical use.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Optical Rotation	-15.0° to -18.0° (c=1 in methanol)

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