Description

Rebamipide Impurity 1 is a specified impurity of the active pharmaceutical ingredient (API) Rebamipide, a medication used for treating gastric ulcers and gastritis. This impurity is a critical reference standard in the pharmaceutical development and manufacturing process, essential for ensuring drug safety, efficacy, and regulatory compliance. It is primarily required by analytical laboratories, quality control (QC) departments, and research institutions involved in the synthesis, purification, and quality assurance of Rebamipide API and its finished dosage forms.

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.
• Method Development and Validation: Used in developing and validating analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Rebamipide.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry R&D: Aids chemists in optimizing synthesis routes to minimize the formation of this specific impurity.

Basic Information

Product Name	Rebamipide Impurity 1
CAS No.	94670-39-0
Molecular Formula	C19H15ClN2O4
Molecular Weight	370.79 g/mol
Synonyms	2-(4-Chlorobenzamido)-3-(2-oxo-2,3-dihydro-1H-benzo[d]imidazol-1-yl)propanoic Acid; OPC-12759 Impurity 1; Rebamipide Related Compound 1; 2-[(4-Chlorobenzoyl)amino]-3-(2-oxo-1H-benzimidazol-1-yl)propanoic Acid; MUCOSTA Impurity 1; UNII-3J8F4S4Q8R
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 standards align with the requirements for pharmaceutical reference materials.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.