Description

Rebamipide 3-Chloro Impurity is a specified organic compound used as a critical reference standard in pharmaceutical development and quality control. This impurity is essential for monitoring and controlling the quality of the active pharmaceutical ingredient (API) Rebamipide, ensuring the final drug product's safety and efficacy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, purification, and validation of Rebamipide-based medications.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of process-related impurities in Rebamipide API.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods for purity analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch testing to ensure Rebamipide API meets stringent pharmacopeial (e.g., USP, EP, JP) and internal specification limits.
• Stability Studies: Used to monitor the formation and levels of this specific degradant in Rebamipide drug products under various storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development (R&D): Facilitates process chemistry research aimed at minimizing or eliminating this impurity during API synthesis.

Basic Information

Product Name	Rebamipide 3-Chloro Impurity
CAS No.	90098-05-8
Molecular Formula	C19H17ClN2O4
Molecular Weight	372.80 g/mol
Synonyms	3-Chloro Rebamipide; 2-(4-Chlorobenzamido)-3-(2-oxo-1,2-dihydroquinolin-4-yl)propanoic Acid; Rebamipide Chloro Impurity; Rebamipide Impurity C; Rebamipide Related Compound C; OPC-12759 3-Chloro Impurity; 4-Quinolinepropanoic acid, α-[(4-chlorobenzoyl)amino]-1,2-dihydro-2-oxo-
EINECS	Contact for details

Quality Control

Our Rebamipide 3-Chloro Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C.

Specification

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

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