Description

Metoclopramide Sulfone is a key pharmaceutical intermediate and impurity reference standard. This compound is critical for ensuring the quality, safety, and efficacy of related drug substances and finished products. It is primarily utilized by research institutions, analytical laboratories, and manufacturers in the pharmaceutical industry for method development, validation, and quality control processes.

Application

• Pharmaceutical Impurity Standard: Serves as a certified reference material (CRM) for the identification and quantification of related substances in Metoclopramide API and formulations.
• Analytical Research & Development: Used in HPLC, LC-MS, and other chromatographic methods for method development and validation studies.
• Quality Control & Assurance: Employed as a system suitability standard and for routine batch testing in pharmaceutical QC laboratories.
• Process Chemistry: Acts as an intermediate or a marker in the synthesis and purification process development of Metoclopramide.
• Regulatory Compliance: Essential for generating impurity profiles and stability data required for regulatory filings (e.g., FDA, EMA).
• Academic & Contract Research: Used in pharmacokinetic, metabolic, and degradation pathway studies in academic and CRO settings.

Basic Information

Product Name	Metoclopramide Sulfone
CAS No.	139339-72-3
Molecular Formula	C14H19ClN2O3S
Molecular Weight	330.83 g/mol
Synonyms	4-Amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide Sulfone; Metoclopramide S,S-Dioxide; Metoclopramide Sulfoxide Impurity; 1-(Diethylamino)-3-methoxy-4-sulfamoyl-5-chlorobenzamide; NSC 339373; UNII-9K8N8P3U3D; Metoclopramide Related Compound F (sulfone)
EINECS	Contact for details

Quality Control

Our Metoclopramide Sulfone is produced under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by IR and NMR, purity assay by HPLC, and control of specified impurities. A detailed Certificate of Analysis (COA) confirming compliance with in-house specifications is provided with every shipment to ensure traceability and reliability for your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Keep the container sealed to protect from moisture.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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