Zhejiang Medicine has patented a method for preparing nemonoxacin malate, an active pharmaceutical ingredient with low impurities. The process involves dissolving nemonoxacin free base and D,L-malic acid in a specific solvent, followed by cooling crystallization and solid-liquid separation to obtain the final product. GlobalData’s report on Zhejiang Medicine gives a 360-degree view of the company including its patenting strategy. Buy the report here.
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According to GlobalData’s company profile on Zhejiang Medicine, Cancer treatment biomarkers was a key innovation area identified from patents. Zhejiang Medicine's grant share as of June 2024 was 46%. Grant share is based on the ratio of number of grants to total number of patents.
Method for preparing nemonoxacin malate active pharmaceutical ingredient
The granted patent US12005059B2 outlines a method for preparing a nemonoxacin malate active pharmaceutical ingredient (API). The process begins with dissolving nemonoxacin free base and D,L-malic acid in a C1-C3 alcohol/water mixed solvent, maintained at a temperature between 50°C and 65°C. The mole ratio of D,L-malic acid to nemonoxacin free base is specified to be between 0.95:1.0 and 1.2:1.0, with the solvent quantity being 8-14 times the weight of the nemonoxacin free base. The method includes cooling crystallization, which can be either direct or gradient cooling, followed by solid-liquid separation, washing, and drying of the precipitated solid to yield the nemonoxacin malate API.
Further claims refine the method by specifying optimal conditions, such as a mixed solvent temperature of 55°C to 60°C, a solvent quantity of 10-12 times the weight of the nemonoxacin free base, and a water to C1-C3 alcohol ratio of 0.5-0.6:1. Additional steps include the use of activated carbon for decolorization prior to crystallization and various temperature ranges for cooling during the crystallization process. The claims also detail specific time frames for stirring and vacuum drying conditions, ensuring the effective production of the nemonoxacin malate API.
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