Description

Itopride Impurity A CAS NO 943518-63-6 is a specified impurity of the pharmaceutical agent Itopride Hydrochloride, used to monitor and control the quality of the active pharmaceutical ingredient (API). This high-purity reference standard is critical for ensuring drug safety and efficacy by enabling accurate analytical method development and validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality assurance and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Itopride Impurity A in Itopride Hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to accurately detect and measure this specific impurity.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to test Itopride Hydrochloride batches against pharmacopeial or internal specifications for impurity profiles.
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions (e.g., heat, humidity, light) to establish drug shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over impurities.
• Research & Development: Supports R&D efforts in process chemistry to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Itopride Impurity A
CAS No.	943518-63-6
Molecular Formula	C20H26N2O4
Molecular Weight	358.44 g/mol
Synonyms	N-[4-[2-(Dimethylamino)ethoxy]benzyl]-3,4-dimethoxybenzamide; Itopride Related Compound A; Itopride EP Impurity A; Itopride Hydrochloride Impurity A; Benzamide, N-[[4-[2-(dimethylamino)ethoxy]phenyl]methyl]-3,4-dimethoxy-; 3,4-Dimethoxy-N-{[4-(2-(dimethylamino)ethoxy]phenyl}methyl)benzamide; UNII-7Q6K5QVL5R
EINECS	Contact for details

Quality Control

Every batch of Itopride Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. 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 in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.