Description

Itopride Impurity C is a specified impurity of the pharmaceutical active ingredient Itopride Hydrochloride, a prokinetic agent. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Itopride-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Itopride Impurity C in drug substances and finished products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency in compliance with ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Facilitates process chemistry research to understand and minimize impurity formation during synthesis.

Basic Information

Product Name	Itopride Impurity C
CAS No.	141996-97-6
Molecular Formula	C20H26N2O4
Molecular Weight	358.44 g/mol
Synonyms	N-[4-[2-(Dimethylamino)ethoxy]benzyl]-3,4-dimethoxybenzamide; Itopride Related Compound C; Itopride EP Impurity C; Itopride Hydrochloride Impurity C; 3,4-Dimethoxy-N-[[4-[2-(dimethylamino)ethoxy]phenyl]methyl]benzamide; Benzamide, N-[[4-[2-(dimethylamino)ethoxy]phenyl]methyl]-3,4-dimethoxy-
EINECS	Contact for details

Quality Control

Every batch of Itopride Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards (EP, USP) and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

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

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