Description

Mosapride Impurity F is a specified impurity of the gastrointestinal prokinetic agent Mosapride Citrate. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is primarily used by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical industry to ensure the purity, safety, and efficacy of Mosapride-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Mosapride Citrate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to confirm impurity levels meet pharmacopeial (e.g., USP, EP, JP) or internal specification limits.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and long-term stability programs.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during API synthesis, helping to optimize manufacturing processes to minimize its generation.

Basic Information

Product Name	Mosapride Impurity F
CAS No.	112914-16-6
Molecular Formula	C21H25ClFN3O3
Molecular Weight	421.89 g/mol
Synonyms	4-Amino-5-chloro-2-ethoxy-N-[[4-[(4-fluorophenyl)methyl]-2-morpholinyl]methyl]benzamide; Desbenzyl Mosapride; 1-(4-Amino-5-chloro-2-ethoxybenzoyl)-4-[(4-fluorobenzyl)aminomethyl]piperidine; Mosapride Des-Benzyl Impurity; Mosapride Related Compound F; UNII-9J3H1B3F2R
EINECS	Contact for details

Quality Control

Every batch of Mosapride Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, NMR, and IR spectroscopy to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your quality and regulatory requirements.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 3.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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