Description

Metoclopramide Impurity 20 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the drug Metoclopramide. It is an essential tool for researchers and quality assurance professionals in the pharmaceutical industry who require reliable reference materials to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Metoclopramide Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Crucial for developing, optimizing, and validating chromatographic methods to separate and accurately measure impurity levels.
• Quality Control & Assurance (QC/QA): Used in routine batch testing within pharmaceutical manufacturing to monitor and control impurity profiles, ensuring compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products in Metoclopramide formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for impurity identification.
• Research & Development: Facilitates studies on the degradation pathways, metabolism, and synthesis of Metoclopramide and related compounds.

Basic Information

Product Name	Metoclopramide Impurity 20
CAS No.	1279870-17-5
Molecular Formula	C14H22ClN3O2
Molecular Weight	299.80 g/mol
Synonyms	4-Amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide impurity; Metoclopramide Related Compound; 1-(Diethylamino)-2-[(4-amino-5-chloro-2-methoxybenzoyl)amino]ethane; Metoclopramide EP Impurity; Metoclopramide USP Impurity; 4-Amino-5-chloro-2-methoxy-N-[2-(diethylamino)ethyl]benzamide impurity; Metoclopramide Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Metoclopramide Impurity 20 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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