Understanding Impurities: The Role of 1-(2,6-Dichlorophenyl)indolin-2-one in Diclofenac Quality
In the rigorous field of pharmaceutical quality control, understanding and managing impurities is paramount. 1-(2,6-Dichlorophenyl)indolin-2-one (CAS: 15362-40-0) holds particular significance in this regard, primarily due to its association with Diclofenac, a widely prescribed anti-inflammatory drug.
This compound is recognized as a potential impurity that can arise during the synthesis and manufacturing of Diclofenac. Specifically, it can be formed through intramolecular cyclization reactions when Diclofenac or its salts are subjected to high temperatures, such as those encountered during autoclave sterilization processes. The presence of 1-(2,6-Dichlorophenyl)indolin-2-one in the final Diclofenac product must be carefully monitored and controlled to ensure product safety and efficacy.
Pharmaceutical manufacturers rely on precise analytical methods to detect and quantify such impurities. Reference standards, like high-purity 1-(2,6-Dichlorophenyl)indolin-2-one, are indispensable tools for this purpose. These standards allow analytical chemists to calibrate instruments, validate testing methods, and ensure that manufactured batches of Diclofenac meet the strict purity requirements set by regulatory bodies.
The chemical structure of 1-(2,6-Dichlorophenyl)indolin-2-one, C14H9Cl2NO, is distinct from Diclofenac, allowing for its differentiation through analytical techniques such as High-Performance Liquid Chromatography (HPLC). Its physical properties, including its solid form and characteristic appearance, also aid in its identification.
For companies involved in pharmaceutical quality assurance, sourcing reliable reference standards and high-quality intermediates is crucial. Suppliers like NINGBO INNO PHARMCHEM CO.,LTD. play a vital role by providing materials like 1-(2,6-Dichlorophenyl)indolin-2-one, ensuring that the pharmaceutical industry has the necessary tools to maintain the highest standards of drug purity and patient safety.
This compound is recognized as a potential impurity that can arise during the synthesis and manufacturing of Diclofenac. Specifically, it can be formed through intramolecular cyclization reactions when Diclofenac or its salts are subjected to high temperatures, such as those encountered during autoclave sterilization processes. The presence of 1-(2,6-Dichlorophenyl)indolin-2-one in the final Diclofenac product must be carefully monitored and controlled to ensure product safety and efficacy.
Pharmaceutical manufacturers rely on precise analytical methods to detect and quantify such impurities. Reference standards, like high-purity 1-(2,6-Dichlorophenyl)indolin-2-one, are indispensable tools for this purpose. These standards allow analytical chemists to calibrate instruments, validate testing methods, and ensure that manufactured batches of Diclofenac meet the strict purity requirements set by regulatory bodies.
The chemical structure of 1-(2,6-Dichlorophenyl)indolin-2-one, C14H9Cl2NO, is distinct from Diclofenac, allowing for its differentiation through analytical techniques such as High-Performance Liquid Chromatography (HPLC). Its physical properties, including its solid form and characteristic appearance, also aid in its identification.
For companies involved in pharmaceutical quality assurance, sourcing reliable reference standards and high-quality intermediates is crucial. Suppliers like NINGBO INNO PHARMCHEM CO.,LTD. play a vital role by providing materials like 1-(2,6-Dichlorophenyl)indolin-2-one, ensuring that the pharmaceutical industry has the necessary tools to maintain the highest standards of drug purity and patient safety.
Perspectives & Insights
Logic Thinker AI
“Reference standards, like high-purity 1-(2,6-Dichlorophenyl)indolin-2-one, are indispensable tools for this purpose.”
Molecule Spark 2025
“These standards allow analytical chemists to calibrate instruments, validate testing methods, and ensure that manufactured batches of Diclofenac meet the strict purity requirements set by regulatory bodies.”
Alpha Pioneer 01
“The chemical structure of 1-(2,6-Dichlorophenyl)indolin-2-one, C14H9Cl2NO, is distinct from Diclofenac, allowing for its differentiation through analytical techniques such as High-Performance Liquid Chromatography (HPLC).”