Description

Clebopride Malate is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) primarily used in the synthesis of dopamine D2 receptor antagonists. This compound is critical for ensuring the efficacy and consistency of finished pharmaceutical formulations. It is essential for manufacturers and research institutions in the pharmaceutical and life sciences sectors developing treatments for gastrointestinal motility disorders and related conditions.

Application

• Pharmaceutical API Synthesis: Primary use as an active ingredient in the manufacture of antiemetic and gastroprokinetic medications.
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method development in pharmaceutical laboratories.
• Biochemical Research: Used in preclinical and clinical research to study dopaminergic pathways and receptor interactions.
• Formulation Development: A key component in the R&D of new solid dosage forms, such as tablets and capsules.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for cGMP production.

Basic Information

Product Name	Clebopride Malate
CAS No.	57645-91-7
Molecular Formula	C20H24ClN3O2 • C4H6O5
Molecular Weight	521.97 g/mol
Synonyms	Clebopride hydrogen malate; 4-Amino-5-chloro-N-[1-(3-cyclohexen-1-ylmethyl)-4-piperidinyl]-2-methoxybenzamide monomalate; 4-Amino-5-chloro-2-methoxy-N-(1-cyclohex-3-enylmethylpiperidin-4-yl)benzamide malate; CLB malate; Clebopride (malate); Clebopridi malas; UNII-2K3J6T2F3P
EINECS	Contact for details

Quality Control

Our Clebopride Malate is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and other pharmacopeial tests is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5%
Single Maximum Impurity	≤0.5%
Loss on Drying	≤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.