Description

Mebeverine Impurity 1 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the antispasmodic drug Mebeverine Hydrochloride during its development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify, quantify, and monitor this specific impurity in Mebeverine Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating sensitive HPLC, UPLC, or GC methods to ensure accurate impurity detection.
• Stability Studies and Forced Degradation: Employed in stability-indicating assays to track impurity levels over time and understand the degradation pathways of Mebeverine.
• Quality Control and Batch Release Testing: Essential for routine QC testing of Mebeverine API to confirm it meets stringent pharmacopeial (e.g., USP, EP) or internal specification limits for impurities.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Used in R&D to study the chemical and metabolic behavior of Mebeverine and its related substances.

Basic Information

Product Name	Mebeverine Impurity 1
CAS No.	1260668-38-9
Molecular Formula	C25H35NO5
Molecular Weight	429.55 g/mol
Synonyms	Mebeverine Related Compound 1; Mebeverine EP Impurity 1; Mebeverine USP Impurity 1; 4-[Ethyl[2-(4-methoxyphenyl)-1-methylethyl]amino]butyl 3,4-dimethoxybenzoate; Verapamil Impurity; Desmethyl Mebeverine; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Our Mebeverine Impurity 1 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity, and related substances by validated methods such as HPLC. We support compliance with ICH Q3A/B guidelines and pharmacopeial standards relevant to impurity characterization.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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