Description

Mosapride Impurity J is a specified impurity of the pharmaceutical active ingredient Mosapride, a gastroprokinetic agent. This compound is critical for analytical reference standards used in the research, development, and quality control of Mosapride-based drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product purity, safety, and compliance with stringent pharmacopeial guidelines.

Application

• Primary use as a certified reference standard (CRS) for analytical method development and validation.
• Critical component in impurity profiling and identification studies for Mosapride Citrate API and finished dosage forms.
• Essential for conducting stability studies to monitor degradation pathways in pharmaceutical formulations.
• Used in pharmacopeial testing to comply with ICH, USP, and EP requirements for impurity limits.
• Serves as a key material in regulatory submissions (e.g., ANDA, NDA) to establish specification limits.
• Utilized in quality control laboratories for the routine testing of Mosapride batches.

Basic Information

Product Name	Mosapride Impurity J
CAS No.	112886-56-3
Molecular Formula	C21H25ClFN3O3
Molecular Weight	421.90 g/mol
Synonyms	4-Amino-5-chloro-2-ethoxy-N-[[4-[(4-fluorophenyl)methyl]-2-morpholinyl]methyl]benzamide; Desbenzyl Mosapride; Mosapride Desbenzyl Impurity; Mosapride Related Compound J; 1-(4-Amino-5-chloro-2-ethoxybenzoyl)-4-[(4-fluorobenzyl)aminomethyl]piperidine; UNII-9Q1VU5E9QH
EINECS	Contact for details

Quality Control

Every batch of Mosapride Impurity J is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines.

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 must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% 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.