Description

Rebamipide 2-Chloro Impurity is a key chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Rebamipide. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of the 2-chloro derivative in Rebamipide API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure Rebamipide batches meet stringent pharmacopeial (e.g., USP, EP, JP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions (forced degradation studies).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of Rebamipide-related substances.

Basic Information

Item	Detail
Product Name	Rebamipide 2-Chloro Impurity
CAS No.	90098-06-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	2-[(4-Chlorobenzoyl)amino]-3-(2-oxo-1,2-dihydroquinolin-4-yl)propanoic Acid; 2-Chloro Rebamipide; Rebamipide Chloro Impurity; Rebamipide Impurity C; Rebamipide Related Compound C; OPC-12759 Impurity; 4-Quinolinone Impurity of Rebamipide
EINECS	Contact for details

Quality Control

Every batch of Rebamipide 2-Chloro Impurity (CAS 90098-06-9) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment to prevent moisture uptake.

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)	≥ 95.0%
Assay (HPLC)	90.0% - 110.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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