Description

Indobufen Impurity 3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Indobufen. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Indobufen API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and release testing of pharmaceutical batches to meet pharmacopeial standards (e.g., ICH Q3A/B).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study metabolic pathways and degradation mechanisms of Indobufen.

Basic Information

Product Name	Indobufen Impurity 3
CAS No.	1379292-20-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-(1-Oxoisoindolin-2-yl)butanoic Acid; 2-[4-(1-Oxo-1,3-dihydro-2H-isoindol-2-yl)butyl]benzoic Acid Impurity; Indobufen Related Compound 3; Indobufen EP Impurity C; Indobufen Process Impurity; 2-[4-(1-Oxoisoindolin-2-yl)butyl]benzoic Acid
EINECS	Contact for details

Quality Control

Our Indobufen Impurity 3 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and spectroscopic methods for structural verification (IR, NMR, MS). We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards align with ICH guidelines to support your regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.