Description

Itopride Hydrochloride is a high-purity pharmaceutical active ingredient (API) primarily used as a prokinetic agent. It is critical for the formulation of medications that enhance gastrointestinal motility and treat functional dyspepsia. This compound is essential for pharmaceutical manufacturers and research institutions developing treatments for upper GI disorders, requiring consistent quality and reliable supply chains to ensure final drug product efficacy and safety.

Application

• Pharmaceutical API: Primary active ingredient in prescription medications for gastroparesis and functional dyspepsia.
• GI Motility Drug Formulation: Used in the development and production of tablets, capsules, and other solid oral dosage forms.
• Clinical Research Material: Serves as a reference standard and raw material in preclinical and clinical studies for new gastrointestinal therapies.
• Generic Drug Manufacturing: Key component for companies producing bioequivalent versions of branded prokinetic drugs.
• Pharmacological Studies: Utilized in academic and industrial research to investigate mechanisms of dopamine D2 receptor antagonism and acetylcholinesterase inhibition.

Basic Information

Product Name	Itopride Hydrochloride
CAS No.	122892-31-3
Molecular Formula	C20H26N2O4 • HCl
Molecular Weight	394.89 g/mol
Synonyms	Itopride HCl; N-[4-[2-(Dimethylamino)ethoxy]benzyl]-3,4-dimethoxybenzamide Hydrochloride; HSDB 7368; Itopridum; Ganaton (brand name); Itopride Monohydrochloride; 4-[2-(Dimethylamino)ethoxy]-N-[[(3,4-dimethoxyphenyl)carbonyl]methyl]benzamide Hydrochloride
EINECS	Contact for details

Quality Control

Our Itopride Hydrochloride is manufactured under strict quality management systems. Each batch is tested to meet high-purity standards suitable for pharmaceutical applications, with comprehensive analytical methods including HPLC, IR, and titration. A Certificate of Analysis (COA) detailing purity, identity, and impurity profiles is provided with every shipment to ensure traceability and compliance.

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 to prevent moisture absorption, which can affect stability and handling properties.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
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)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%

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