Sucralose

As a representative category in the high-intensity sweetener field, sucralose is a non-nutritive artificially synthesized sweetener. Its mechanism of action is to modify the hydroxyl structure of sucrose molecules, achieving an approximately 600-fold increase in sweetness while retaining the pure flavor of sucrose. Moreover, it is not metabolized or absorbed by the human body, does not participate in blood glucose fluctuations, and carries no risk of dental caries. This product is widely used in special foods for diabetic patients and people pursuing weight loss, as well as in multiple fields such as beverages, baked goods, pharmaceutical preparations, and oral care products, making it one of the most widely applied sweetener varieties globally.

At present, the annual global market size of sucralose has exceeded RMB 7 billion, with a compound annual growth rate of around 8% in the past five years. China is the core producer of sucralose worldwide, with its production capacity accounting for more than 90% of the global total. The industry has a relatively high concentration, with the top 3 enterprises occupying approximately 70% of the domestic production capacity. As global sugar reduction policies continue to be implemented, the replacement demand in downstream food and beverage and pharmaceutical sectors is still being released. It is expected that the market size will maintain a steady growth rate of more than 6% in the next three years.

Sucralose was originally developed by Tate & Lyle, a British company, under the trade name Splenda. The core compound patent was filed in 1976, and all patents in major global markets expired in 2000. Currently, the mainstream marketed dosage forms include food-grade crystalline powder and pharmaceutical-grade powder, with a common specification of 25kg per barrel. Its pharmaceutical-grade product has been included in the U.S. FDA Reference Listed Drug Catalog, and is also listed in the Chinese List of Chemical Drugs. As of now, China NMPA has approved sucralose API registrations from multiple enterprises, all with DMF status A. A number of oral preparations containing sucralose as a flavoring agent have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of sucralose 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 comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the full-process needs of API enterprises for quality research, registration and declaration, and routine testing.