Description

(4-Carboxy-3-Ethoxy)Phenyl Acetic Acid (Repaglinide Impurity) is a high-purity chemical reference standard and a key process-related impurity in the synthesis of the antidiabetic drug Repaglinide. Its primary value lies in enabling rigorous quality control and analytical method development for pharmaceutical manufacturers, ensuring the safety and efficacy of the final drug product. This compound is essential for research and quality assurance laboratories in the pharmaceutical industry, particularly those focused on active pharmaceutical ingredient (API) development, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Repaglinide API and finished dosage forms.
• Analytical Method Development & Validation: A critical component for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control the levels of this specific impurity, ensuring it remains within ICH (International Council for Harmonisation) guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity samples for stability studies and specification setting.
• Process Chemistry Research: Used by chemists to study and optimize the Repaglinide synthesis pathway, helping to minimize the formation of this impurity.
• Academic & Contract Research: Serves as a research tool in universities and CROs (Contract Research Organizations) for studies related to diabetes drug metabolism and impurity synthesis.

Basic Information

Product Name	(4-Carboxy-3-Ethoxy)Phenyl Acetic Acid (Repaglinide Impurity)
CAS No.	503834-19-3
Molecular Formula	C12H14O5
Molecular Weight	238.24 g/mol
Synonyms	2-(4-Carboxy-3-ethoxyphenyl)acetic acid; 4-Carboxy-3-ethoxyphenylacetic Acid; 3-Ethoxy-4-carboxyphenylacetic Acid; Repaglinide Impurity; Repaglinide Related Compound; AG-EE 388 ZW; UNII-8V3Y0K3F4H; (4-Carboxy-3-ethoxyphenyl)acetic Acid
EINECS	Contact for details

Quality Control

Every batch of (4-Carboxy-3-Ethoxy)Phenyl Acetic Acid is manufactured and tested under a strict quality management system. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification, meeting the stringent requirements for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical results is provided with each shipment.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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