Acesulfame

The R&D of high-intensity sweeteners is an important direction in the field of food and pharmaceutical excipients. As a high-intensity sweetener of the dihydrooxathiazine class, acesulfame generates sweetness signals by acting on the sweetness recognition sites of human taste receptors. Its sweetness can reach 200 times that of sucrose, and it has stable properties, no calories, and is not absorbed by the human body during metabolism. It is often used as a flavoring agent in oral preparations, covering multiple dosage forms such as granules, oral solutions, and buccal tablets, and is suitable for medication groups that need to control sucrose intake, such as diabetic patients and obese people. It can also be used for the formula development of health food.

At present, the global market size of high-intensity sweeteners has exceeded 18 billion yuan, and the compound annual growth rate in the past five years has remained at around 7%. Among them, acesulfame has a steadily increasing market share year by year due to its good stability and outstanding synergistic sweetening effect. Domestic production capacity of acesulfame accounts for more than 85% of the total global production capacity, with a high concentration of leading manufacturing enterprises. With the expansion of flavoring demand from downstream generic drugs and the sugar-free food market, the demand for acesulfame API is expected to maintain an annual growth rate of more than 6% in the next three years.

Acesulfame was first developed by Hoechst AG in Germany, with the trade name of Acesulfame K, and its core compound patent expired in 1992. There are more than 10 domestic manufacturers of marketed acesulfame API, most of which have completed API registration with CDE with the status of A, which can be directly associated with preparation applications. Meanwhile, acesulfame has been included in the *Chinese Pharmacopoeia* 2020 edition, and is also listed in the FDA Inactive Ingredient Guide, and can be used as a flavoring excipient for oral preparations. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of acesulfame impurity reference standards. Most of the products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the quality control needs of different R&D and production scenarios such as API quality research and preparation stability investigation.