葡甲胺

In the fields of osmotic pressure regulation and drug solubilization, meglumine, as a typical substance with dual attributes of organic amine pharmaceutical excipient and active pharmaceutical ingredient, is widely used in multiple therapeutic areas such as contrast media, anti-infectives, and antipyretic analgesics, relying on its core characteristics that salt formation with acidic drugs can significantly improve drug solubility and reduce vascular irritation. Its mechanism of action is to form stable ion pairs with acidic active ingredients such as iodinated contrast media and non-steroidal anti-inflammatory drugs, which not only improves the water solubility of drugs to facilitate preparation development, but also allows slow dissociation in vivo to ensure drug efficacy release. It is an indispensable key raw material in the development of diagnostic preparations and injections, applicable to the full age group ranging from patients with common infections to those requiring enhanced CT examinations.

The global meglumine market size was approximately USD 210 million in 2023, with a compound annual growth rate maintained at around 4.8%. The growth momentum mainly comes from the steady rise in global demand for imaging diagnosis and the expansion of generic drug preparation pipelines. From the perspective of competitive landscape, China is the world's core producer of meglumine, with production capacity accounting for more than 65% of the total global supply. Products of leading domestic enterprises have passed FDA and CEP certifications and are supplied to the European and American markets. In the domestic market in recent years, with the advancement of centralized procurement of contrast media, the concentration of demand for active pharmaceutical ingredients continues to increase, and downstream preparation enterprises have further expanded the demand for compliant and stably supplied active pharmaceutical ingredients.

As a mature variety, the relevant information of the original research of meglumine has entered the public domain. At present, nearly 30 domestic enterprises have completed CDE registration for meglumine active pharmaceutical ingredients, most of which are in status A and can be directly associated with preparation applications. The domestically approved preparations containing meglumine cover dozens of varieties such as iopromide injection, meglumine diatrizoate injection, and lysine acetylsalicylate powder, most of which have been included in the reference preparation catalogue. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of meglumine impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of active pharmaceutical ingredient enterprises in the process of process research, impurity research and preparation application, providing stable material basis support for the whole process of R&D and production.