Description

Rebamipide Impurity 1 is a specified impurity of the active pharmaceutical ingredient (API) Rebamipide, used in the development and quality control of related pharmaceutical products. This compound is critical for ensuring the purity, safety, and regulatory compliance of Rebamipide-based drug formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Rebamipide Impurity 1 in drug substances and products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.

Basic Information

Product Name	Rebamipide Impurity 1
CAS No.	100342-53-8
Molecular Formula	C19H15ClN2O4
Molecular Weight	370.79 g/mol
Synonyms	2-(4-Chlorobenzamido)-3-(2-oxo-1,2-dihydroquinolin-4-yl)propanoic Acid; 4-Chloro-N-[1-carboxy-2-(2-oxo-1,2-dihydroquinolin-4-yl)ethyl]benzamide; Rebamipide Related Compound A; Rebamipide Impurity A; OPC-12759 Impurity 1; 2-[(4-Chlorobenzoyl)amino]-3-(2-oxo-1,2-dihydro-4-quinolinyl)propanoic Acid
EINECS	Contact for details

Quality Control

Our Rebamipide Impurity 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established specifications. Our quality commitment aligns with cGMP principles and relevant ICH guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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