Description

Betahistine Dihydrochloride is a high-purity pharmaceutical active ingredient primarily used as a histamine analog. This compound is critical for the formulation of medications targeting vestibular disorders, offering reliable therapeutic action. It is essential for pharmaceutical manufacturers, research institutions, and developers of finished dosage forms requiring a consistent and high-quality API. The product is supplied under stringent quality controls to ensure it meets the exacting standards of the global pharmaceutical industry.

Application

• Active Pharmaceutical Ingredient (API) in the manufacture of prescription medications for Meniere's disease and related vestibular vertigo.
• Key intermediate in advanced pharmaceutical research and development of neurological therapeutics.
• Reference standard for quality control and analytical testing in pharmaceutical laboratories.
• Raw material for the development of generic drug formulations.
• Component in clinical trial materials for investigating new treatments for balance disorders.

Basic Information

Product Name	Betahistine Dihydrochloride
CAS No.	5579-84-0
Molecular Formula	C8H12N2·2HCl
Molecular Weight	209.11 g/mol
Synonyms	Betahistine HCl; 2-[2-(Methylamino)ethyl]pyridine dihydrochloride; Serc (brand name); β-Histine dihydrochloride; Betahistinum dihydrochloridum; BHC; N-Methyl-2-pyridineethanamine dihydrochloride
EINECS	226-941-3

Quality Control

Our Betahistine Dihydrochloride is manufactured and tested to meet high-purity standards suitable for pharmaceutical applications. Quality assurance protocols are in place to ensure batch-to-batch consistency and compliance with relevant pharmacopeial guidelines. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with each shipment to guarantee traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place 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.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF Titration)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%

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