Description

o-Desmethyl Mebeverine Acid CAS NO 586357-02-0 is a key pharmaceutical intermediate and metabolite of the antispasmodic drug mebeverine. This compound is of critical importance for analytical development, pharmacokinetic studies, and the synthesis of related therapeutic agents. It is primarily required by pharmaceutical R&D laboratories, quality control departments, and manufacturers of active pharmaceutical ingredients (APIs) for method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantification and identification of mebeverine metabolites in bioanalytical studies.
• Impurity Standard: Used in the development and validation of HPLC/LC-MS methods to monitor and control related substances in mebeverine API and finished dosage forms.
• Metabolite Research: Essential for conducting pharmacokinetic (PK) and pharmacodynamic (PD) studies to understand the drug's metabolism and elimination pathways.
• Chemical Synthesis Intermediate: Acts as a crucial building block in the research-scale synthesis of novel mebeverine analogs or derivatives for new drug discovery.
• Quality Assurance & Control: Employed by QA/QC laboratories to ensure batch-to-batch consistency and compliance with regulatory specifications for impurity limits.
• Regulatory Submissions: Provides necessary data and characterization for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	o-Desmethyl Mebeverine Acid
CAS No.	586357-02-0
Molecular Formula	C21H27NO5
Molecular Weight	373.45 g/mol
Synonyms	4-[Ethyl[2-(4-methoxyphenyl)-1-methylethyl]amino]butyl 3,4-dimethoxybenzoate; Mebeverine Acid Metabolite; Desmethyl Mebeverine Acid; Mebeverine o-Desmethyl Acid; 3,4-Dimethoxybenzoic Acid 4-[Ethyl[2-(4-methoxyphenyl)-1-methylethyl]amino]butyl Ester; Mebeverine Metabolite D6 (unlabeled); o-Desmethyl Mebeverine Alcohol Acid
EINECS	Contact for details

Quality Control

Our o-Desmethyl Mebeverine Acid is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide detailed Certificates of Analysis (COA) with each shipment, ensuring traceability and compliance with ICH guidelines for impurities. Custom synthesis and purification to meet specific pharmacopeial or client specifications are available.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to maximize stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%
Heavy Metals	≤ 20 ppm

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