Description

Bepotastine Besilate is a potent, selective histamine H1-receptor antagonist used as the active pharmaceutical ingredient (API) in ophthalmic and oral formulations. This compound is critical for the development of effective anti-allergic medications, offering relief from symptoms associated with allergic conjunctivitis and other hypersensitivity reactions. It is primarily required by pharmaceutical manufacturers, R&D laboratories, and contract development and manufacturing organizations (CDMOs) engaged in the production of advanced ophthalmic solutions and systemic allergy treatments.

Application

• Primary Active Pharmaceutical Ingredient (API) in anti-allergic ophthalmic solutions and eye drops.
• Key component in the formulation of oral tablets for systemic allergy relief.
• Reference standard for analytical method development and quality control in pharmaceutical laboratories.
• Intermediate in advanced pharmaceutical research for novel histamine H1-receptor antagonists.
• Raw material for contract manufacturing of generic and branded anti-allergic medications.
• Used in preclinical and clinical studies investigating new therapeutic applications for allergic diseases.

Basic Information

Product Name	Bepotastine Besilate
CAS No.	190786-44-8
Molecular Formula	C21H25ClN2O3 • C7H6O3S
Molecular Weight	547.06 g/mol
Synonyms	Bepotastine Besylate; (+)-(S)-4-[4-(4-Chlorophenyl)-2-pyridyl]butyl-1-piperidinecarboxylate benzenesulfonate; TAU-284; Bepreve (Brand Name); Bepotastine Besilate (JP17); Bepotastine Besylate (USAN); 1-Piperidinecarboxylic acid, 4-[4-(4-chlorophenyl)-2-pyridinyl]butyl ester, (S)-, compd. with benzenesulfonic acid (1:1)
EINECS	Contact for details

Quality Control

Our Bepotastine Besilate is manufactured under strict quality management systems. It undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided with each batch to support regulatory compliance and customer quality assurance processes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which can affect stability and handling properties.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (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	Specific range provided on COA

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