Description

Indobufen Impurity 2 Sodium Salt is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of related substances during the manufacturing and quality assurance of the antiplatelet drug Indobufen. It is primarily utilized by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and fine chemical industries to ensure product safety, efficacy, and compliance with stringent global regulatory standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the calibration of analytical instruments (HPLC, LC-MS) in method development and validation.
• Impurity Profiling and Characterization: Used to identify and quantify this specific impurity in Indobufen Active Pharmaceutical Ingredient (API) and finished drug products.
• Quality Control and Assurance (QC/QA): Enables routine batch testing to ensure impurity levels remain within International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance and Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to demonstrate control over the drug substance's impurity profile.
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions to establish product shelf life.
• Research and Development: Supports process chemistry research aimed at minimizing or eliminating the formation of this impurity during synthesis.

Basic Information

Product Name	Indobufen Impurity 2 Sodium Salt
CAS No.	937671-41-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Indobufen Related Compound 2 Sodium Salt; Sodium 2-[4-(1-oxo-2-isoindolinyl)phenyl]butyrate; Indobufen Sodium Salt Impurity 2; 2-[4-(1-Oxo-2-isoindolinyl)phenyl]butyric Acid Sodium Salt; Indobufen EP Impurity B Sodium Salt; Indobufen USP Impurity Sodium Salt
EINECS	Contact for details

Quality Control

Our Indobufen Impurity 2 Sodium Salt is manufactured and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting the results against stringent in-house specifications. Our quality commitment supports compliance with ICH Q3A, Q3B guidelines and relevant pharmacopoeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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