Description

o-Desmethyl Metoclopramide, Hydrochloride is a high-purity pharmaceutical intermediate and reference standard, critical for research and development in the field of analytical chemistry and drug metabolism. This compound is essential for method validation, impurity profiling, and pharmacokinetic studies related to metoclopramide. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in quality control and regulatory compliance activities.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of metabolites in drug substance and product analysis.
• Impurity Profiling: Critical for monitoring and controlling the related substance o-desmethyl metoclopramide in metoclopramide active pharmaceutical ingredient (API) and finished dosage forms.
• Metabolite Studies: Employed in in vitro and in vivo metabolism research to understand the biotransformation pathways of metoclopramide.
• Bioanalytical Method Development: Serves as a key analyte for developing and validating HPLC, LC-MS, and other chromatographic methods in biological matrices.
• Pharmacokinetic Research: Utilized in studies investigating the absorption, distribution, metabolism, and excretion (ADME) of metoclopramide.
• Quality Control & Assurance: Integral to the quality control protocols of API manufacturers to ensure product purity and compliance with pharmacopeial standards (e.g., USP, EP).

Basic Information

Product Name	o-Desmethyl Metoclopramide, Hydrochloride
CAS No.	38059-78-8
Molecular Formula	C13H19ClN2O2 • HCl
Molecular Weight	311.22 g/mol
Synonyms	4-Amino-5-chloro-N-(2-(diethylamino)ethyl)-2-methoxybenzamide Hydrochloride; Desmethyl Metoclopramide Hydrochloride; Metoclopramide Impurity D (Hydrochloride); Metoclopramide Metabolite Hydrochloride; Nor-Metoclopramide Hydrochloride; 5-Chloro-2-methoxy-4-(2-(diethylamino)ethylamino)benzamide Hydrochloride; O-Desmethylmetoclopramide HCl
EINECS	Contact for details

Quality Control

Our o-Desmethyl Metoclopramide, Hydrochloride is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis to ensure compliance with ICH guidelines and relevant industry standards. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (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%
Heavy Metals	≤20 ppm

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