Description

Indobufen Impurity A is a designated reference standard used for the analytical profiling and quality control of the pharmaceutical substance Indobufen. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic and spectroscopic analyses. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Indobufen Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical component in developing, optimizing, and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to monitor impurity levels against established specifications to ensure compliance with pharmacopeial standards (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive understanding and control of the drug substance's impurity profile.
• Research & Development: Supports synthetic route optimization and process chemistry studies by helping to identify and control this impurity during API manufacturing.

Basic Information

Product Name	Indobufen Impurity A
CAS No.	858847-40-2
Molecular Formula	C19H19NO4
Molecular Weight	325.36 g/mol
Synonyms	4-(1,3-Dihydro-1-oxo-2H-isoindol-2-yl)-α-ethylbenzenebutanoic Acid; 2-[4-(2-Carboxybutyl)phenyl]isoindolin-1-one; Indobufen Related Compound A; Indobufen Impurity; Indobufen EP Impurity A; Indobufen USP Impurity A
EINECS	Contact for details

Quality Control

Every batch of Indobufen Impurity A (CAS 858847-40-2) is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for use as a reference material. 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 in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storage under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 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.