Description

Trimebutine is a spasmolytic agent belonging to the class of antimuscarinic and calcium channel blocking compounds, widely recognized for its therapeutic applications. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of finished pharmaceutical formulations. It is primarily utilized by pharmaceutical manufacturers and research institutions in the development and production of medications targeting functional gastrointestinal disorders.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for the treatment of irritable bowel syndrome (IBS) and other functional bowel disorders.
• Gastrointestinal Spasmolytic Formulations: Incorporated into tablets, capsules, and other oral dosage forms designed to relieve abdominal pain and discomfort associated with intestinal motility issues.
• Clinical Research: Serves as a reference standard and key material in pharmacological studies and clinical trials investigating gastrointestinal physiology and new therapeutic agents.
• Generic Drug Manufacturing: Essential for the production of generic versions of trimebutine-based drugs, ensuring bioequivalence and regulatory compliance.
• Veterinary Pharmaceuticals: Potential application in veterinary medicine for managing gastrointestinal spasms in animals.

Basic Information

Product Name	Trimebutine
CAS No.	39133-31-8
Molecular Formula	C22H29NO5
Molecular Weight	387.47 g/mol
Synonyms	Trimebutine Maleate (common salt form); 3,4,5-Trimethoxybenzoic acid 2-(dimethylamino)-2-phenylbutyl ester; 2-(Dimethylamino)-2-phenylbutyl 3,4,5-trimethoxybenzoate; Debridat; Polibutin; Mebutin; Trimedat; Modulon; Spabucol
EINECS	254-326-0

Quality Control

Our Trimebutine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical use, including identification, assay, and impurity profile analysis. Certificates of Analysis (COA) documenting compliance with in-house specifications are available upon request. We support our clients in meeting the stringent requirements of global regulatory bodies.

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 prevent moisture absorption, which could affect stability and handling properties.

Specification

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

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