Description

Itopride Impurity 1 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Itopride hydrochloride, a prokinetic agent. It is primarily required by analytical laboratories and pharmaceutical manufacturers engaged in method development, stability studies, and impurity profiling. Ensuring the identity and purity of this impurity is fundamental to meeting stringent pharmacopeial standards for drug substance and product specifications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Itopride API and finished dosage forms.
• Analytical Method Development and Validation: Used as a known impurity to develop, optimize, and validate chromatographic methods, primarily HPLC and UPLC.
• Stability and Forced Degradation Studies: Employed to identify and monitor degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release Testing: Essential for setting specification limits and conducting routine QC testing to ensure Itopride batches meet ICH guidelines for impurity thresholds.
• Regulatory Documentation: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research and Development: Used in pharmacokinetic and metabolic studies to understand the impurity's profile and potential impact.

Basic Information

Product Name	Itopride Impurity 1
CAS No.	2332724-21-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Itopride Related Compound 1; Itopride Impurity A; Itopride EP Impurity A; Itopride Hydrochloride Impurity 1; N-[4-[2-(Dimethylamino)ethoxy]benzyl]-3,4-dimethoxybenzamide Impurity; 4-[2-(Dimethylamino)ethoxy]benzyl 3,4-dimethoxybenzoate Impurity
EINECS	Contact for details

Quality Control

Every batch of Itopride Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. Keep the container sealed to protect the material from moisture absorption and contamination.

Specification

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

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