Description

Metoclopramide N4-Sulfonate is a key pharmaceutical intermediate and impurity reference standard. This compound is critical for ensuring the quality, safety, and efficacy of metoclopramide-based drug products through rigorous analytical control. It is primarily required by pharmaceutical manufacturers, research institutions, and quality control laboratories engaged in the development and production of antiemetic and gastroprokinetic medications.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of process-related impurities in Metoclopramide Hydrochloride API.
• Essential analytical marker in HPLC and LC-MS methods for drug substance and finished product quality control.
• Critical raw material in research and development of novel metoclopramide derivatives or metabolite studies.
• Used in stability studies to monitor degradation pathways and establish shelf-life for metoclopramide formulations.
• Serves as a calibration standard in regulatory submissions and pharmacopoeial testing (e.g., USP, EP) to ensure compliance.
• Important intermediate for synthetic chemistry in academic and industrial settings exploring sulfonated organic compounds.

Basic Information

Product Name	Metoclopramide N4-Sulfonate
CAS No.	27260-42-0
Molecular Formula	C14H22ClN3O4S
Molecular Weight	363.86 g/mol
Synonyms	4-Amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide N4-Sulfonate; Metoclopramide Sulfonate; Metoclopramide Impurity; 4-Amino-5-chloro-2-methoxy-N-(2-(diethylamino)ethyl)benzamide Sulfonate; Benzamide, 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy-, sulfonate; UNII-9F8N8X1G1T
EINECS	Contact for details

Quality Control

Our Metoclopramide N4-Sulfonate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity assessment by HPLC, and control of related substances and residual solvents. Certificates of Analysis (COA) with detailed chromatographic data are provided for every shipment to ensure traceability and compliance with ICH guidelines and customer-specific requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry 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 matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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