Description

Desmethyl Trimebutine Hcl is a key pharmaceutical intermediate and active metabolite of the spasmolytic agent trimebutine. This compound is of significant value in the development and quality control of gastrointestinal therapeutics, serving as a critical reference standard. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development, impurity profiling, and metabolic studies for antispasmodic medications.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of trimebutine and related therapeutic agents.
• Analytical Reference Standard: Used for the identification, assay, and impurity quantification of trimebutine in drug substances and finished products via HPLC, LC-MS, and other chromatographic methods.
• Metabolite Studies: Essential for pharmacokinetic and pharmacodynamic research to understand the metabolism and activity of trimebutine.
• Impurity Standard: Serves as a certified reference material for monitoring and controlling specified impurities in accordance with ICH guidelines.
• Research & Development: Utilized in preclinical and clinical research for developing new formulations and studying mechanism of action.
• Quality Control (QC) & Quality Assurance (QA): Integral for ensuring batch-to-batch consistency and compliance with pharmacopoeial standards (e.g., USP, EP) in pharmaceutical manufacturing.

Basic Information

Product Name	Desmethyl Trimebutine Hcl
CAS No.	84333-59-5
Molecular Formula	C19H29NO4 • HCl
Molecular Weight	371.90 g/mol
Synonyms	2-(Dimethylamino)-2-phenylbutyl 3,4,5-trimethoxybenzoate hydrochloride; 3,4,5-Trimethoxybenzoic acid 2-(dimethylamino)-2-phenylbutyl ester hydrochloride; Trimebutine Metabolite; De-Methyl Trimebutine Hydrochloride; Nor-Trimebutine Hydrochloride; N-Desmethyl Trimebutine Hydrochloride; (2-Phenyl-2-((dimethylamino)methyl)butyl) 3,4,5-trimethoxybenzoate hydrochloride
EINECS	Contact for details

Quality Control

Our Desmethyl Trimebutine Hcl is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure high purity and consistency, meeting the stringent requirements for pharmaceutical reference standards and intermediates. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided with every shipment.

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 (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤1.0%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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