Diatrizoic Acid

As a classic iodinated contrast agent API, diatrizoic acid belongs to the category of ionic organic iodinated contrast agents. Its mechanism of action relies on the iodine atoms in its molecular structure to absorb X-rays, which can clearly display the morphological contours of lumens such as blood vessels and urinary tracts in clinical applications. It is mainly used for urography, cardiovascular angiography, cerebral angiography and other lumen contrast examinations, and its applicable population covers patients of all ages who need the above imaging examinations. It is one of the contrast agent raw materials with a long application history and sufficient safety verification in clinical radiological diagnosis.

At present, the scale of the global contrast agent market maintains steady growth, and the overall scale has exceeded USD 6 billion in 2023, among which iodinated contrast agents account for more than 70%. Diatrizoic acid is one of the core varieties of traditional iodinated contrast agents. Although the market share of non-ionic contrast agents has continued to increase in recent years, there is still stable demand in the primary medical market and some specific contrast scenarios. Domestic diatrizoic acid manufacturers are mainly generic pharmaceutical enterprises, and a competitive pattern dominated by 3-5 large-scale suppliers has been formed at present. After the implementation of the volume-based procurement policy, the price of related preparations has become reasonable, and the demand for upstream APIs maintains a steady growth rate of about 3% per year.

The original research enterprise of diatrizoic acid is Bayer, and the original research trade name is "Urografin" (meglumine diatrizoate injection, a compound preparation of diatrizoic acid and meglumine). Its core compound patent expired worldwide in the 1970s. The main dosage form approved by the original research is injection, and common specifications include 1ml:0.3g, 20ml:12g, etc. This original research preparation has been included in the FDA Reference Listed Drug Catalog, and is also included in China's *Catalog of Reference Listed Drugs of Chemical Drugs*. Data from the domestic API registration platform show that 5 domestic enterprises have completed the A-status registration of diatrizoic acid APIs, and another 3 are under review. Domestic approved and marketed diatrizoic acid-related preparations include meglumine diatrizoate injection, sodium diatrizoate injection and other varieties. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of diatrizoic acid impurity reference standards. Most products are available in stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the needs of API enterprises and preparation manufacturers for quality research, stability study and registration declaration.