Description

(4-Carboxy-3-Ethoxy)Phenyl Acetic Acid (Repaglinide Impurity) is a high-purity chemical reference standard of critical importance in the pharmaceutical industry. This compound serves as a key impurity standard for the quality control and regulatory compliance of the active pharmaceutical ingredient (API) Repaglinide, an oral anti-diabetic medication. It is essential for analytical laboratories, API manufacturers, and regulatory bodies involved in method development, validation, and batch release testing to ensure drug safety and efficacy. The precise characterization of this impurity is fundamental to meeting stringent pharmacopeial standards for drug substance purity.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of the specified impurity in Repaglinide API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH Q3A/B guidelines.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to confirm that Repaglinide batches meet the specified impurity limits as per USP, EP, or other pharmacopeial monographs.
• Regulatory Submissions & Compliance: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed to track the formation and level of this impurity during forced degradation and long-term stability studies of Repaglinide.
• Research & Development: Used in pharmaceutical R&D to study the synthesis pathway, degradation chemistry, and purification processes of Repaglinide.

Basic Information

Item	Details
Product Name	(4-Carboxy-3-Ethoxy)Phenyl Acetic Acid (Repaglinide Impurity)
CAS No.	220438-80-2
Molecular Formula	C13H14O5
Molecular Weight	250.25 g/mol
Synonyms	2-(4-Carboxy-3-ethoxyphenyl)acetic acid; 2-[4-Carboxy-3-ethoxyphenyl]acetic acid; 4-Carboxy-3-ethoxybenzeneacetic acid; Repaglinide Impurity; Repaglinide Related Compound; 220438-80-2; (4-Carboxy-3-ethoxy)benzeneacetic acid
EINECS	Contact for details

Quality Control

Every batch of (4-Carboxy-3-Ethoxy)Phenyl Acetic Acid is manufactured and tested under strict quality management systems. The material is characterized using advanced analytical techniques including HPLC, GC, MS, NMR, and IR to confirm identity, purity, and structure. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against predefined specifications. Our quality commitment aligns with the standards required for pharmaceutical reference materials, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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