Description

Betahistine Methanesulfonate is a high-purity pharmaceutical active ingredient, specifically the methanesulfonate salt form of betahistine. This compound is valued for its critical role in the synthesis of finished dosage forms targeting specific neurological and vestibular disorders. It is primarily required by pharmaceutical manufacturers and advanced research institutions for the development and production of prescription medications.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of prescription drugs for the treatment of Ménière's disease and related vestibular conditions.
• Neurological Research: Used as a reference standard and active compound in preclinical and clinical studies investigating histamine H1 and H3 receptor modulation.
• Finished Dosage Form Manufacturing: Serves as the key API in the production of tablets and other oral solid dosage forms.
• Analytical Standard: Employed in quality control laboratories for HPLC, GC, or spectroscopic assay method development and validation.
• Process Development: Utilized in pharmaceutical R&D for scaling up synthesis and optimizing purification processes.
• Regulatory Submissions: Sourced as a characterized material for inclusion in regulatory dossiers (e.g., DMF, CMC sections) for drug approval.

Basic Information

Product Name	Betahistine Methanesulfonate
CAS No.	380416-14-8
Molecular Formula	C8H12N2 • CH4O3S
Molecular Weight	328.41 g/mol
Synonyms	Betahistine Mesylate; 2-[2-(Methylamino)ethyl]pyridine methanesulfonate; Betahistine methane sulfonate salt; Serc (brand name reference); N-Methyl-2-pyridineethanamine methanesulfonate; Betahistini methanesulfonas; Betahistinum
EINECS	Contact for details

Quality Control

Our Betahistine Methanesulfonate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and strength, suitable for pharmaceutical applications. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment.

Storage

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

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0%
Single Unknown Impurity	≤ 0.1%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w
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.