Description

Metoclopramide Monohydrochloride Monohydrate is a high-purity pharmaceutical active ingredient (API) and key intermediate, essential for ensuring the efficacy and safety of final drug formulations. Its primary value lies in its role as the monohydrate salt form of metoclopramide, offering enhanced stability and consistent bioavailability for therapeutic use. This compound is critically needed by pharmaceutical manufacturers, research institutions, and fine chemical suppliers engaged in the development and production of antiemetic and gastroprokinetic medications.

Application

• Pharmaceutical API Manufacturing: Primary use as the active pharmaceutical ingredient in antiemetic and gastroprokinetic drug formulations.
• Generic Drug Production: Serves as a critical raw material for the synthesis of generic metoclopramide tablets, injections, and oral solutions.
• Clinical Research & Development: Used as a reference standard and building block in preclinical and clinical studies for gastrointestinal motility disorders.
• Veterinary Medicine: Employed in the formulation of veterinary pharmaceuticals for the control of nausea and vomiting in animals.
• Fine Chemical Synthesis: Acts as a key intermediate for further chemical modifications and the synthesis of novel derivatives.
• Analytical Reference Standard: Utilized in quality control laboratories for HPLC, UV, and other analytical method development and validation.

Basic Information

Product Name	Metoclopramide Monohydrochloride Monohydrate
CAS No.	54143-57-6
Molecular Formula	C14H22ClN3O2 • HCl • H2O
Molecular Weight	354.27 g/mol
Synonyms	4-Amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide monohydrochloride monohydrate; Metoclopramide HCl monohydrate; Metoclopramide hydrochloride hydrate; Reglan (API); Maxolon; Primperan; CAS 54143-57-6; 4-Amino-5-chloro-2-methoxy-N-(2-(diethylamino)ethyl)benzamide hydrochloride monohydrate
EINECS	Contact for details

Quality Control

Our Metoclopramide Monohydrochloride Monohydrate is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure compliance with pharmaceutical-grade standards, including identity, purity, and impurity profile verification. We support our commitment to quality with comprehensive documentation, and a Certificate of Analysis (COA) is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent moisture absorption.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	4.5% - 6.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%

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