Iopamidol

As a representative variety of non-ionic low-osmolar iodine contrast agents, iopamidol achieves high X-ray attenuation characteristics through the combination of a triiodobenzene ring structure. Meanwhile, the modification of hydrophilic side chains greatly reduces its osmotic pressure and chemical toxicity. Compared with traditional ionic contrast agents, its incidence of allergic reactions and risk of renal injury are significantly lower. At present, it is widely used clinically in angiography, urography, CT enhanced scanning and various types of body cavity contrast examinations, covering adults, children and special populations including those with renal insufficiency. It is one of the commonly used drugs with the optimal balance between safety and imaging quality in the current field of contrast examination.

The domestic market size of iodine contrast agents has exceeded 17 billion yuan. As a clinically rigid-demand variety, iopamidol accounts for about 12% of the market share, with a stable annual growth rate of around 7%. Due to the high technical requirements for iodine raw material purification and preparation sterility control in the production of contrast agents, the current market presents a pattern of coexistence of original research drugs and leading generic pharmaceutical enterprises, among which imported products account for about 55%. In recent years, with the advancement of consistency evaluation, the market share of domestic generic drugs is gradually increasing. In multiple rounds of provincial centralized procurement since 2022, the average price reduction of winning bids for iopamidol injection has reached 48%, further promoting the improvement of clinical penetration rate.

The original research enterprise of iopamidol is Bracco, and the original trade name is Iopamiro. Its core compound patent expired in China in 2017, and the patents in major European and American markets also expired around 2016. At present, the dosage forms of the original research drug approved in China are mainly injections, covering 10ml/10g, 30ml/9g, 50ml/15g, 100ml/30g, 100ml/37g and other specifications. It has been included in the *Reference Preparation Catalogue of Chemical Drugs* issued by NMPA, and is also listed in the FDA Reference Preparation Catalogue. In terms of domestic API registration, 7 enterprises including the original research enterprise have had their iopamidol APIs registered and approved by CDE, among which 5 are domestic enterprises. On the preparation side, more than 12 domestic enterprises have obtained approval for the marketing of iopamidol injection, most of which have passed the consistency evaluation. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the qualitative and quantitative requirements for impurities in the process of generic iopamidol R&D and quality control, CATO can provide a full set of impurity reference standards for this API, supporting full coverage from process impurities to degradation impurities. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can be directly used in research links such as methodological validation and stability investigation.