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    CRYSTALS OF LAQUINIMOD SODIUM AND IMPROVED PROCESS FOR THE MANUFACTURE THEREOF
    9.
    发明申请
    CRYSTALS OF LAQUINIMOD SODIUM AND IMPROVED PROCESS FOR THE MANUFACTURE THEREOF 有权
    LAQUINIMOD SODIUM水晶及其制造方法改进

    公开(公告)号：US20140271878A1

    公开(公告)日：2014-09-18

    申请号：US14214191

    申请日：2014-03-14

    申请人： Anton Frenkel ,  Avital Laxer

    发明人： Anton Frenkel ,  Avital Laxer

    IPC分类号： C07D215/56

    CPC分类号： C07D215/56 ,  A61K31/47 ,  C07B2200/13 ,  G01N30/06 ,  G01N33/15

    摘要： The subject invention provides a mixture of crystalline laquinimod sodium particles, wherein (i) 90% or more of the total amount by volume of the laquinimod sodium particles have a size of 40 microns or less or (ii) 50% or more of the total amount by volume of the laquinimod sodium particles have a size of 15 microns or less, and wherein: a) the mixture has a bulk density of 0.2 g/mL to 0.4 g/mL; b) the mixture has a tapped density of 0.40 g/mL to 0.7 g/mL; c) an amount of heavy metal in the mixture is no more than 0.002% of heavy metal relative to the amount by weight of laquinimod sodium; d) an amount of 5-chloro-4-hydroxy-1-methyl-2-oxo-1,2-dihydroquinoline (MCQ) in the mixture is no more than 0.15% relative to the amount of laquinimod sodium as measured by HPLC; e) an amount of 5-chloro-4-hydroxy-1-methyl-2-oxo-1,2-dihydroqunoline-3-carboxylic acid (MCQCA) in the mixture is no more than 0.15% relative to the amount of laquinimod sodium as measured by HPLC; or f) an amount of methyl 5-chloro-4-hydroxy-1-methyl-2-oxo-1,2-dihydroquinoline-3-carboxylate (MCQME) in the mixture is no more than 0.12% relative to the amount of laquinimod sodium as measured by HPLC.

    摘要翻译： 本发明提供结晶laquinimod钠颗粒的混合物，其中（i）拉喹莫德钠颗粒的总体积的90％或更多具有40微米或更小的尺寸或（ii）总量的50％或更多 拉喹莫德钠颗粒的体积量具有15微米或更小的尺寸，并且其中：a）混合物的堆积密度为0.2g / mL至0.4g / mL; b）混合物的密度为0.40g / mL至0.7g / mL; c）混合物中重金属的量相对于拉喹莫德钠的重量计不超过0.002％重金属; d）混合物中5-氯-4-羟基-1-甲基-2-氧代-1,2-二氢喹啉（MCQ）的量相对于通过HPLC测定的拉喹莫德钠的量不超过0.15％; e）混合物中5-氯-4-羟基-1-甲基-2-氧代-1,2-二氢喹啉-3-羧酸（MCQCA）的量相对于拉喹莫德钠的量不超过0.15％ 通过HPLC测量; 或f）混合物中5-氯-4-羟基-1-甲基-2-氧代-1,2-二氢喹啉-3-羧酸甲酯（MCQME）的量相对于拉喹莫德的量不超过0.12％ 通过HPLC测量的钠。

    Crystals of laquinimod sodium and improved process for the manufacture thereof
    10.
    发明授权
    Crystals of laquinimod sodium and improved process for the manufacture thereof 有权
    拉喹莫德钠晶体及其制备方法

    公开(公告)号：US09233927B2

    公开(公告)日：2016-01-12

    申请号：US14214191

    申请日：2014-03-14

    申请人： Anton Frenkel ,  Avital Laxer

    发明人： Anton Frenkel ,  Avital Laxer

    IPC分类号： C07D215/56

    CPC分类号： C07D215/56 ,  A61K31/47 ,  C07B2200/13 ,  G01N30/06 ,  G01N33/15

    摘要： The subject invention provides a mixture of crystalline laquinimod sodium particles, wherein (i) 90% or more of the total amount by volume of the laquinimod sodium particles have a size of 40 microns or less or (ii) 50% or more of the total amount by volume of the laquinimod sodium particles have a size of 15 microns or less, and wherein: a) the mixture has a bulk density of 0.2 g/mL to 0.4 g/mL; b) the mixture has a tapped density of 0.40 g/mL to 0.7 g/mL; c) an amount of heavy metal in the mixture is no more than 0.002% of heavy metal relative to the amount by weight of laquinimod sodium; d) an amount of 5-chloro-4-hydroxy-1-methyl-2-oxo-1,2-dihydroquinoline (MCQ) in the mixture is no more than 0.15% relative to the amount of laquinimod sodium as measured by HPLC; e) an amount of 5-chloro-4-hydroxy-1-methyl-2-oxo-1,2-dihydroqunoline-3-carboxylic acid (MCQCA) in the mixture is no more than 0.15% relative to the amount of laquinimod sodium as measured by HPLC; or f) an amount of methyl 5-chloro-4-hydroxy-1-methyl-2-oxo-1,2-dihydroquinoline-3-carboxylate (MCQME) in the mixture is no more than 0.12% relative to the amount of laquinimod sodium as measured by HPLC.

    摘要翻译： 本发明提供结晶laquinimod钠颗粒的混合物，其中（i）拉喹莫德钠颗粒的总体积的90％或更多具有40微米或更小的尺寸或（ii）总量的50％或更多 拉喹莫德钠颗粒的体积量具有15微米或更小的尺寸，并且其中：a）混合物的堆积密度为0.2g / mL至0.4g / mL; b）混合物的密度为0.40g / mL至0.7g / mL; c）混合物中重金属的量相对于拉喹莫德钠的重量计不超过0.002％重金属; d）混合物中5-氯-4-羟基-1-甲基-2-氧代-1,2-二氢喹啉（MCQ）的量相对于通过HPLC测定的拉喹莫德钠的量不超过0.15％; e）混合物中5-氯-4-羟基-1-甲基-2-氧代-1,2-二氢喹啉-3-羧酸（MCQCA）的量相对于拉喹莫德钠的量不超过0.15％ 通过HPLC测量; 或f）混合物中5-氯-4-羟基-1-甲基-2-氧代-1,2-二氢喹啉-3-羧酸甲酯（MCQME）的量相对于拉喹莫德的量不超过0.12％ 通过HPLC测量的钠。