Description

Mosapride Impurity 4 is a designated impurity reference standard used in the analytical profiling and quality control of the pharmaceutical active ingredient, Mosapride. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Mosapride API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure Mosapride batches comply with pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Mosapride.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA) with agencies like the FDA and EMA.
• Research & Development: Supports impurity profiling during the synthesis process development and optimization of Mosapride.

Basic Information

Product Name	Mosapride Impurity 4
CAS No.	2196138-12-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-Amino-5-chloro-2-ethoxy-N-[[4-(4-fluorobenzyl)-2-morpholinyl]methyl]benzamide Impurity 4; Mosapride Related Compound 4; Mosapride EP Impurity D; Gasmotin Impurity 4; UNII-Contact for details
EINECS	Contact for details

Quality Control

Our Mosapride Impurity 4 is manufactured under strict quality control protocols to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each lot is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity confirmation, and impurity profile as determined by advanced analytical techniques like HPLC and MS. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccator or under an inert atmosphere to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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