Description

Itopride Impurity B CAS NO 331239-23-7 is a high-purity chemical reference standard, specifically identified as a key impurity of the gastrointestinal prokinetic agent Itopride Hydrochloride. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, particularly those involved in method development, stability studies, and regulatory compliance for Itopride-based formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Itopride Hydrochloride and related drug products.
• Analytical Method Development and Validation: Crucial for developing, optimizing, and validating HPLC, UPLC, or GC methods to separate and quantify impurities in active pharmaceutical ingredients (APIs).
• Quality Control and Assurance (QC/QA): Used in routine batch testing of Itopride API and finished dosage forms to monitor impurity profiles and ensure they meet pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Research and Development: Serves as a critical tool in synthetic chemistry R&D to understand impurity formation pathways and optimize purification processes.

Basic Information

Product Name	Itopride Impurity B
CAS No.	331239-23-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-[4-[2-(Dimethylamino)ethoxy]benzyl]-3,4-dimethoxybenzamide Impurity B; Itopride Related Compound B; 4-[2-(Dimethylamino)ethoxy]benzyl 3,4-dimethoxybenzoate; Itopride EP Impurity B; Itopride Hydrochloride Impurity B; Itopride Process Impurity; Benzamide, N-[[4-[2-(dimethylamino)ethoxy]phenyl]methyl]-3,4-dimethoxy- (related substance)
EINECS	Contact for details

Quality Control

Every batch of Itopride Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (e.g., HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture uptake, which could affect stability and analytical performance. Handle with standard laboratory precautions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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