Crystal form of pyrroloquinoline quinone dipotassium salt and preparation method thereof

By adding an organic solvent dropwise to an aqueous solution of pyrroloquinoline quinone dipotassium salt and controlling the crystallization, a stable crystal form was prepared, overcoming the limitations of amorphous salts in pharmaceutical formulations and improving stability and production efficiency.

CN122444726APending Publication Date: 2026-07-24SHANDONG YUANLITAI MEDICAL TECH CO LTD +1
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Patent Information

Application Number
CN202610698701.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-05-20
Publication Date
2026-07-24

AI Technical Summary

Technical Problem

Most existing pyrroloquinoline quinone dipotassium salts are amorphous, which limits their application in pharmaceutical formulations. Furthermore, there is a lack of polymorphic systems with excellent physicochemical properties and efficient and controllable preparation methods.

Method used

By adding different kinds of organic solvents, such as methanol, N,N-dimethylformamide, isopropanol, acetonitrile, or 1,4-dioxane, to an aqueous solution of pyrroloquinoline quinone dipotassium salt, and controlling the formation of crystal nuclei during the cooling and static crystallization process, a crystal form with characteristic peaks was prepared.

Benefits of technology

The obtained crystal form is stable under high temperature and high humidity conditions, and is not easily transformed or degraded, which improves the stability and safety of pharmaceutical preparations, simplifies the production process, and is suitable for large-scale industrial production.

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Abstract

The invention belongs to the technical field of organic compound crystallization, and relates to a crystal form of pyrroloquinoline quinone dipotassium salt and a preparation method thereof. The crystal form has a peak at a specific position in an X-ray powder diffraction pattern which is radiated by Cu-K alpha and is expressed by a 2 theta angle. The crystal form of the pyrroloquinoline quinone dipotassium salt provided by the invention has good physical stability, is not liable to crystal transformation or degradation under high-temperature and high-humidity conditions, and is beneficial to the application of the pyrroloquinoline quinone dipotassium salt in preparations (especially pharmaceutical preparations).
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