Description

Trimebutine Maleate is a pharmaceutical-grade active pharmaceutical ingredient (API) with the CAS registry number 34140-59-5. It is a spasmolytic agent that acts on the gastrointestinal tract, offering a critical therapeutic solution for functional bowel disorders. This high-purity compound is essential for manufacturers in the global pharmaceutical industry developing treatments for conditions like irritable bowel syndrome (IBS).

Application

• Pharmaceutical API: Primary active ingredient in prescription medications for gastrointestinal motility disorders.
• Antispasmodic Formulations: Used in the development of drugs targeting abdominal pain and discomfort associated with IBS.
• Gastroprokinetic Agents: Key component in formulations designed to modulate intestinal smooth muscle activity.
• Finished Dosage Forms: Incorporated into tablets, capsules, and other solid oral dosage forms.
• Clinical Research: Serves as a reference standard and raw material for pharmacological studies and new drug development.
• Generic Drug Manufacturing: Critical for producing cost-effective generic versions of branded spasmolytic medications.

Basic Information

Product Name	Trimebutine Maleate
CAS No.	34140-59-5
Molecular Formula	C22H29NO5 • C4H4O4
Molecular Weight	503.55 g/mol
Synonyms	2-(Dimethylamino)-2-phenylbutyl 3,4,5-trimethoxybenzoate maleate; Trimebutine hydrogen maleate; 3,4,5-Trimethoxybenzoic acid 2-(dimethylamino)-2-phenylbutyl ester maleate; Polibutin; Debridat; Mebutin; Trimedat; Modulon
EINECS	Contact for details

Quality Control

Our Trimebutine Maleate is manufactured under strict quality systems to meet the rigorous standards of the global pharmaceutical industry. Each batch is tested to ensure compliance with relevant pharmacopoeial monographs (such as USP/EP) and internal specifications. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles is provided with every shipment to guarantee traceability and batch-to-batch consistency.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a 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 or almost white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.5% - 101.5% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm

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