Description

Betahistine is a synthetic histamine analog primarily used as an active pharmaceutical ingredient (API). This compound is valued for its specific pharmacological activity in modulating histamine receptors within the inner ear. It is essential for manufacturers in the pharmaceutical industry developing treatments for vestibular disorders, such as Ménière's disease. Our supply ensures high purity and consistent quality for critical pharmaceutical synthesis.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for vertigo and dizziness associated with Ménière's disease.
• Vestibular Disorder Treatment: Formulation into tablets, capsules, and other oral dosage forms to manage symptoms like tinnitus, hearing loss, and balance issues.
• Clinical Research: Serves as a reference standard and key intermediate in pharmacological studies and new drug development targeting the histaminergic system.
• Generic Drug Manufacturing: Sourcing for the production of cost-effective generic versions of branded vertigo medications for global markets.

Basic Information

Product Name	Betahistine
CAS No.	5638-76-6
Molecular Formula	C8H12N2
Molecular Weight	136.20 g/mol
Synonyms	2-[2-(Methylamino)ethyl]pyridine; Betahistine dihydrochloride (salt form); Serc; β-histine; Vasomotal; Microser; Vertisan; Betaserc
EINECS	227-078-2

Quality Control

Our Betahistine is manufactured and tested to meet stringent pharmaceutical-grade standards. Quality assurance protocols are designed to ensure identity, purity, strength, and composition. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results from tests including identification, assay, and impurity profiling. We adhere to current Good Manufacturing Practices (cGMP) to support our clients' regulatory compliance for API sourcing.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to 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%

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