Description

Indobufen Impurity 2 is a specified impurity of the antiplatelet drug Indobufen, identified by the CAS registry number 881650-49-3. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this specific impurity during drug substance manufacturing. It is an essential material for analytical method development, validation, and quality assurance processes in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Indobufen.
• Analytical Method Development: Used to develop and validate HPLC, UPLC, or GC methods for impurity profiling of Indobufen API.
• Quality Control & Assurance: Serves as a system suitability and identification standard in the routine QC testing of Indobufen batches to ensure compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions.
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this impurity.

Basic Information

Product Name	Indobufen Impurity 2
CAS No.	881650-49-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Indobufen Related Compound 2; Indobufen Impurity B; 2-[4-(1-Oxoisoindolin-2-yl)phenyl]butyric Acid (probable structure based on naming); 881650-49-3; Indobufen EP Impurity B; Indobufen Process Impurity; Indobufen Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Indobufen Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (e.g., HPLC, GC-MS, NMR) to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (typically 15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
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.