Description

Indobufen Impurity 9 is a designated impurity standard of the antiplatelet drug Indobufen. This compound is critical for pharmaceutical research and development, serving as a key reference marker for ensuring drug purity, safety, and regulatory compliance. It is primarily utilized by analytical laboratories, quality control departments, and R&D teams in the pharmaceutical industry for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Indobufen active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating chromatographic methods (HPLC, UPLC) to accurately identify and quantify this specific impurity.
• Stability Studies: Employed to monitor the formation and levels of this impurity during forced degradation and long-term stability studies of Indobufen.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Indobufen to minimize the formation of this impurity.

Basic Information

Product Name	Indobufen Impurity 9
CAS No.	76553-18-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	2-[4-(1-Oxoisoindolin-2-yl)phenyl]butyric acid; Indobufen Related Compound; Indobufen Process Impurity; 4-(1-Oxo-1,3-dihydro-2H-isoindol-2-yl)benzenebutanoic acid; 2-[p-(1-Oxoisoindolin-2-yl)phenyl]butyric acid; Indobufen Impurity C (Potential designation); 76553-18-9; 4-(1-Oxo-1,3-dihydro-2H-isoindol-2-yl)benzenebutanoic acid
EINECS	Contact for details

Quality Control

Our Indobufen Impurity 9 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with in-house specifications and supporting its use as a reference standard.

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 should be handled in a dry environment to prevent degradation. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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