Description

n-Desethyl Metoclopramide CAS NO 27260-19-1 is a key pharmaceutical intermediate and metabolite of the antiemetic drug metoclopramide. Its primary value lies in its critical role in the research, development, and quality control of pharmaceuticals, particularly for metabolism studies and impurity profiling. This compound is essential for analytical laboratories, pharmaceutical R&D departments, and manufacturers requiring high-purity reference standards to ensure drug safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of metoclopramide and its related substances in drug products.
• Metabolite Studies: Critical for in-vitro and in-vivo pharmacokinetic and metabolism research to understand the biotransformation pathways of metoclopramide.
• Impurity Profiling: Serves as a specified impurity standard for method development and validation in HPLC, LC-MS, and other analytical techniques to monitor drug purity.
• Pharmacological Research: Employed in studies investigating the structure-activity relationship (SAR) of metoclopramide analogs and their metabolites.
• Quality Control (QC) Testing: An essential component in the QC laboratories of API manufacturers and finished dosage form producers to comply with ICH guidelines on impurities.
• Regulatory Submissions: Used to generate data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and ensure drug safety profiles.

Basic Information

Product Name	n-Desethyl Metoclopramide
CAS No.	27260-19-1
Molecular Formula	C12H16ClN3O2
Molecular Weight	269.73 g/mol
Synonyms	Desethylmetoclopramide; 4-Amino-5-chloro-N-(2-(diethylamino)ethyl)-2-methoxybenzamide (Metoclopramide Impurity); Metoclopramide Impurity C; Metoclopramide Metabolite; 4-Amino-5-chloro-2-methoxy-N-[2-(diethylamino)ethyl]benzamide; 27260-19-1; UNII-2U8Q96ORL5
EINECS	Contact for details

Quality Control

Our n-Desethyl Metoclopramide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with relevant pharmacopeial standards for reference materials. Our quality commitment supports your regulatory and research 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 product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment away from direct light exposure to maintain stability and purity.

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)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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