Description

Betahistine Mesylate is a high-purity pharmaceutical active ingredient, a salt form of the histamine analog betahistine. It is a critical intermediate and active pharmaceutical ingredient (API) used in the manufacture of finished dosage forms. This compound is essential for pharmaceutical manufacturers and research institutions developing treatments for vestibular disorders. Our supply is characterized by stringent quality control and reliable global logistics.

Application

• Pharmaceutical API: Primary use as the active ingredient in the formulation of tablets and other dosage forms for the treatment of Ménière's disease and related vertigo symptoms.
• Clinical Research: Utilized in preclinical and clinical studies investigating therapies for inner ear and balance disorders.
• Reference Standard: Serves as a high-purity analytical standard for quality control testing in pharmaceutical laboratories.
• Formulation Development: Used in R&D for developing new drug delivery systems, such as sustained-release or fast-dissolving formulations.
• Generic Drug Manufacturing: A key component for companies producing generic versions of betahistine-based medications.
• Chemical Synthesis: Acts as a stable salt form for further chemical modification or synthesis of related derivatives in medicinal chemistry.

Basic Information

Product Name	Betahistine Mesylate
CAS No.	54856-23-4
Molecular Formula	C8H12N2 • CH4O3S
Molecular Weight	328.43 g/mol
Synonyms	Betahistine Methanesulfonate; 2-[2-(Methylamino)ethyl]pyridine Methanesulfonate; Serc (as brand name reference); Betahistine Mesilate; Microser (as brand name reference); Betaserc (as brand name reference); Histamine H1-receptor agonist (partial); N-Methyl-2-pyridineethanamine methanesulfonate
EINECS	Contact for details

Quality Control

Our Betahistine Mesylate is manufactured under strict quality management systems. Each batch is tested to meet high-purity standards suitable for pharmaceutical applications, with specifications aligning with major pharmacopoeial guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, assay, purity, and related substances. We ensure traceability and compliance with cGMP principles for active pharmaceutical ingredients.

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 off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0%
Single Maximum Unknown Impurity	≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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