METHODS FOR ANALYZING STABILITY OF AN ACTIVE PHARMACEUTICAL INGREDIENT

    公开(公告)号:US20190219555A1

    公开(公告)日:2019-07-18

    申请号:US16245703

    申请日:2019-01-11

    IPC分类号: G01N33/15 H01J49/00 H01J49/04

    摘要: The invention generally relates to methods for analyzing stability of an active pharmaceutical agent. In certain aspects, the methods involve obtaining an active pharmaceutical agent, and distributing the active pharmaceutical agent into one or more microdroplets. The one or more microdroplets including the active pharmaceutical agent are then subjected to one or more conditions that force degradation of the active pharmaceutical agent in each of the one or more microdroplets. The one or more microdroplets are then analyzed to determine a ratio of the active pharmaceutical agent to that of a degradation product of the active pharmaceutical agent, thereby analyzing stability of an active pharmaceutical agent.

    Methods for analyzing stability of an active pharmaceutical ingredient

    公开(公告)号:US11209411B2

    公开(公告)日:2021-12-28

    申请号:US16245703

    申请日:2019-01-11

    IPC分类号: G01N33/15 H01J49/04 H01J49/00

    摘要: The invention generally relates to methods for analyzing stability of an active pharmaceutical agent. In certain aspects, the methods involve obtaining an active pharmaceutical agent, and distributing the active pharmaceutical agent into one or more microdroplets. The one or more microdroplets including the active pharmaceutical agent are then subjected to one or more conditions that force degradation of the active pharmaceutical agent in each of the one or more microdroplets. The one or more microdroplets are then analyzed to determine a ratio of the active pharmaceutical agent to that of a degradation product of the active pharmaceutical agent, thereby analyzing stability of an active pharmaceutical agent.