Description

Mosapride Impurity K is a specified impurity and degradation product of the pharmaceutical active ingredient Mosapride Citrate. This compound is critical for ensuring the quality, safety, and efficacy of the final drug product through rigorous analytical control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for use as a reference standard in method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Mosapride Citrate drug substance and finished products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure drug substance and product compliance with ICH Q3A/B guidelines on impurities.
• Stability Studies: Used to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control.
• Research & Development: Supports process chemistry research to understand and minimize impurity formation during synthesis.

Basic Information

Product Name	Mosapride Impurity K
CAS No.	112886-58-5
Molecular Formula	C21H25ClFN3O3
Molecular Weight	421.90 g/mol
Synonyms	4-Amino-5-chloro-2-ethoxy-N-[[4-[(4-fluorophenyl)methyl]morpholin-2-yl]methyl]benzamide; Desbenzyl Mosapride; Mosapride Desbenzyl Impurity; Mosapride EP Impurity K; Mosapride Related Compound K; UNII-6J5T9Y3H6M; 6J5T9Y3H6M
EINECS	Contact for details

Quality Control

Our Mosapride Impurity K is manufactured and controlled under a strict quality management system. Each batch is subjected to comprehensive analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. Certificates of Analysis (COA) are provided, detailing the results for identity, purity, and related substances. The material is suitable for use as a pharmaceutical impurity reference standard in compliance with ICH guidelines.

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 light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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