Description

Betahistine Hydrochloride is a high-purity pharmaceutical active ingredient, a histamine analog primarily used in the treatment of vestibular disorders. Its core value lies in its ability to improve blood flow in the inner ear, effectively managing symptoms like vertigo, dizziness, and tinnitus associated with Ménière's disease. This compound is essential for pharmaceutical manufacturers and research institutions developing and producing ethical medications for neurological and otological conditions. We supply it in grades suitable for formulation into tablets and other dosage forms, ensuring reliability for critical healthcare applications.

Application

• Pharmaceutical Formulations: Primary active ingredient in prescription medications for the treatment of Ménière's disease and related vestibular syndromes.
• Vertigo Management: Used in drugs aimed at reducing the frequency and severity of vertigo attacks.
• Tinnitus Relief: Incorporated into therapeutic regimens designed to alleviate the perception of ringing in the ears.
• Clinical Research: Serves as a reference standard and key material in pharmacological studies and clinical trials for new vestibular therapies.
• Generic Drug Manufacturing: Critical for producers of generic versions of branded betahistine medications.
• Hospital & Compounding Pharmacies: Used in specialized preparations where customized dosing is required.

Basic Information

Product Name	Betahistine Hydrochloride
CAS No.	15430-48-5
Molecular Formula	C8H12N2•2HCl
Molecular Weight	209.11 g/mol
Synonyms	Betahistine HCl; 2-[2-(Methylamino)ethyl]pyridine Dihydrochloride; Serc; Vasomotal; β-histine; Microser; Vertisan; Betaserc
EINECS	239-426-6

Quality Control

Our Betahistine Hydrochloride is manufactured under strict quality systems, with testing protocols designed to meet or exceed pharmacopeial standards. Each batch is subjected to comprehensive analysis including identification, assay, impurity profiling, and residual solvent testing to ensure high purity and consistency. Certificates of Analysis (COA) documenting full compliance with specifications are provided with every shipment. We support customers requiring alignment with ICH guidelines, GMP principles, and specific regulatory submissions.

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 nature, the container must be kept tightly sealed after opening to prevent moisture absorption, which can affect stability and handling properties.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.5% - 101.5% (on anhydrous basis)
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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