Description

Metoclopramide N4-β-D-Glucuronide is a major, pharmacologically inactive metabolite of the antiemetic drug metoclopramide, formed via glucuronidation. This reference standard is critical for pharmaceutical research and development, particularly in the fields of drug metabolism and pharmacokinetics (DMPK). It is primarily used by analytical laboratories and pharmaceutical companies for method development, validation, and bioanalytical studies to ensure accurate quantification of metoclopramide and its metabolites in biological matrices.

Application

• Bioanalytical Reference Standard: Serves as a certified standard for the quantitative analysis of metoclopramide and its metabolites in plasma, serum, and urine via LC-MS/MS or HPLC.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic pathways, clearance mechanisms, and excretion profiles of metoclopramide.
• Clinical Research and Toxicology: Used to support clinical trials by monitoring drug exposure and understanding patient-specific metabolic variations.
• Pharmaceutical Quality Control: Employed in the development and validation of impurity profiling methods for metoclopramide drug substances and products.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) requiring comprehensive metabolite identification and quantification.

Basic Information

Product Name	Metoclopramide N4-β-D-Glucuronide
CAS No.	27313-54-8
Molecular Formula	C22H27ClN2O8
Molecular Weight	482.91 g/mol
Synonyms	Metoclopramide N4-Glucuronide; 4-Amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide N4-β-D-Glucopyranosiduronic Acid; Metoclopramide Glucuronide; N-Glucuronyl Metoclopramide; 4-(β-D-Glucopyranuronosylamino)-5-chloro-2-methoxy-N-(2-(diethylamino)ethyl)benzamide; 5-Chloro-2-methoxy-4-(β-D-glucopyranosiduronic acid amino)-N-(2-(diethylamino)ethyl)benzamide
EINECS	Contact for details

Quality Control

Our Metoclopramide N4-β-D-Glucuronide is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We support compliance with ICH guidelines for impurities and can provide materials suitable for use in GLP/GMP-regulated environments upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. This compound is hygroscopic (moisture-sensitive); allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
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.