Description

Metoclopramide Impurity F is a specified impurity and reference standard used in the analytical profiling of the antiemetic drug Metoclopramide. This compound is critical for pharmaceutical quality control and regulatory compliance, ensuring the purity and safety of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, process validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Metoclopramide Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, validating, and transferring High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in quality control laboratories.
• Stability Studies & Forced Degradation: Employed to monitor the formation of degradation products in Metoclopramide under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data to agencies like the US FDA and EMA.
• Process Chemistry Research: Used to study and optimize the synthesis pathway of Metoclopramide to minimize the formation of this specific impurity.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability test component and for routine batch release testing of Metoclopramide API.

Basic Information

Product Name	Metoclopramide Impurity F
CAS No.	38339-95-6
Molecular Formula	C14H22ClN3O2
Molecular Weight	299.80 g/mol
Synonyms	4-Amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide; 5-Chloro-2-methoxy-4-aminobenzoyldiethylaminoethylamide; Metoclopramide Related Compound F; Metoclopramide EP Impurity F; Metoclopramide USP Related Compound F; 1-(Diethylamino)-2-[(5-chloro-2-methoxy-4-aminobenzoyl)amino]ethane
EINECS	Contact for details

Quality Control

Every batch of Metoclopramide Impurity F is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with each shipment, supporting compliance with current Good Manufacturing Practices (cGMP) and relevant pharmacopoeial guidelines (USP, EP).

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 must be kept in a desiccated environment to maintain stability and purity.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.