Iopamidol Impurities

General Information

Iopamidol Impurities and Iopamidol  

Daicel Pharma synthesizes impurity standards for Iopamidol, an active pharmaceutical ingredient. We offer crucial impurity standards such as 2,3- Dihydroxy propyl isomer /Iso Iopamidol, Bis-Dimethylamino Iopamidol, Hydroxy ethyl derivative(or) butryl (or) EP Impurity-J, Iso Iso Iopamidol, N, N Dimethyl amino derivative, Dimethyl amino Iopamidol, Iopamidol EP Impurity-F, and O-Acetyl Iopamidol/ AP ADI, which play a vital role in evaluating the purity, and safety of Iopamidol. Daicel Pharma also gives a custom synthesis of Iopamidol impurity standards to meet specific client needs and worldwide delivery options.

Iopamidol [CAS: 60166-93-0] is a non-ionic, water-soluble contrast agent used in radiological procedures such as myelography, arthrography, nephroangiography, arteriography, etc. It’s a benzenedicarboxamide compound and acts as a radioopaque medium in these procedures.

Iopamidol: Use and Commercial Availability  

Isovue-128, Isovue-200, etc., are the brands under which Iopamidol is available. It is a non-ionic, water-soluble radiographic contrast medium containing organic iodine. Iopamidol serves the purpose of blocking X-rays, allowing the visualization of body structures that lack iodine. The degree of opacity observed is directly related to the amount of the iodinated contrast agent present in the path of the X-rays. The distribution and elimination of Iopamidol play a crucial role in visualizing body structures.

Iopamidol Structure and Mechanism of Action

The chemical name of Iopamidol is N1, N3-Bis[2-hydroxy-1-(hydroxymethyl)ethyl]-5-[[(2S)-2-hydroxy-1-oxopropyl]amino]-2,4,6-triiodo-1,3-benzenedicarboxamide. Its chemical formula is C₁₇H₂₂I₃N₃O₈, and its molecular weight is approximately 777.1 g/mol.

Iopamidol enhances computed tomographic brain imaging with radiographic efficiency.

Iopamidol Impurities and Synthesis

The control and analysis of impurities in Iopamidol are crucial for ensuring its quality and safety as a radiographic contrast medium. They can arise from various sources, including the synthesis process and storage conditions. It is essential to monitor and control impurity levels at each preparation stage. Analytical techniques such as high-performance liquid chromatography (HPLC) and mass spectrometry (MS) help in impurity profiling and quantification. Stringent quality control measures can meet regulatory requirements and maintain the purity and safety of Iopamidol. Regular testing and monitoring help minimize impurities and ensure the desired quality of the contrast agent.

Daicel Pharma, in adherence to cGMP standards, operates an analytical facility where we prepare Iopamidol impurity standards like 2,3- Dihydroxy propyl isomer /Iso Iopamidol, Bis-Dimethylamino Iopamidol, Hydroxy ethyl derivative(or) butryl (or) EP Impurity-J, Iso Iso Iopamidol, N, N Dimethyl amino derivative, Dimethyl amino Iopamidol, Iopamidol EP Impurity-F, and O-Acetyl Iopamidol/ AP ADI. We offer a comprehensive Certificate of Analysis (CoA) for these impurity standards, providing a detailed characterization report. The CoA includes data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis. Upon request, we give additional data like 13C-DEPT. We can synthesize unknown Iopamidol impurity standards or degradation products. Each delivery has a comprehensive characterization report.