Fosun PharmaceuPharmacopeia as an Official Control Product

August 1, 2024  Source: drugdu 85

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On July 23, 2024, Guilin Nanopharm received a letter from the United States Pharmacopeial Convention (hereinafter referred to as USP) "Donation Recognition Program Team", which mentioned that the artesunate control product donated by Guilin Nanopharm has been listed as an official control product by USP.

 

Artesunate is the original anti-malarial drug developed by Guilin Pharmaceuticals for the secondary research and development of artemisinin. It solved the problem of water solubility of artemisinin and obtained the certificate of Class I New Drug No. X-01 issued by the Ministry of Health of China in 1987.

 

The control of Artesunate was calibrated by Guilin Southern Pharmaceuticals and USP official laboratories respectively, and the content determination results were identical, both were 99.8%. The data of infrared, mass spectrometry, nuclear magnetic resonance (NMR), related substances, moisture and other assays showed complete match. The inclusion of this control as an official control by USP further proves that the testing capability of Guilin Nanmao R&D Laboratory has reached the international first-class level. Meanwhile, we hope that through this donation, we can further promote the development of global antimalarial drugs and provide more effective solutions to reduce the transmission and treatment of malaria.

 

Source from:website

 

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