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    DIRECT SOLID SAMPLE ANALYTICAL TECHNOLOGY FOR DETERMINING A CONTENT AND A UNIFORMITY THEREOF IN A LYOPHILIZED KIT OF A SULFUR-CONTAINING CHELATOR WITH A STABLE COMPLEX CAPACITY FOR RADIOTECHNETIUM (TC-99M) AND RADIORHENIUM (RE-186, RE-188)
    1.
    发明申请
    DIRECT SOLID SAMPLE ANALYTICAL TECHNOLOGY FOR DETERMINING A CONTENT AND A UNIFORMITY THEREOF IN A LYOPHILIZED KIT OF A SULFUR-CONTAINING CHELATOR WITH A STABLE COMPLEX CAPACITY FOR RADIOTECHNETIUM (TC-99M) AND RADIORHENIUM (RE-186, RE-188) 有权
    用于确定具有稳定的放射性复合容量（TC-99M）和放射性阳离子（RE-186，RE-188）的具有稳定复合容量的含硫化合物的LYOPHILIZED试剂盒中的内容物和其均匀性的直接固体样品分析技术

    公开(公告)号：US20120101741A1

    公开(公告)日：2012-04-26

    申请号：US13273346

    申请日：2011-10-14

    申请人： KUNG-TIEN LIU ,  Ming-Yu Chao ,  Yi-Chih Hsia ,  Shih-Woei Yeh ,  Mei-Hsiu Liao ,  Lee-Chung Men ,  Lie-Hang Shen

    发明人： KUNG-TIEN LIU ,  Ming-Yu Chao ,  Yi-Chih Hsia ,  Shih-Woei Yeh ,  Mei-Hsiu Liao ,  Lee-Chung Men ,  Lie-Hang Shen

    IPC分类号： G06F19/00

    CPC分类号： A61K51/0478

    摘要： The present invention is related to a direct solid sample analytical technology for determining a content and a uniformity thereof in a lyophilized kit of a sulfur-containing chelator with a stable complex capacity for radiotechnetium (Tc-99m) and radiorhenium (Re-186, Re-188). An economical, stable and easily accessible coal standard is used herein as a contrast substance to construct a sulfur calibration curve, followed by obtaining the sulfur content and the uniformity thereof in the solid lyophilized sample by interpolating the foregoing result into the sulfur calibration curve. Then, the weight content percent is converted to get the content and the uniformity of the chelator in the lyophilized kit. The quality control of active pharmaceutical ingredients (API) in the lyophilized kit during key production processes and clinical applications is thus assured.

    摘要翻译： 本发明涉及一种直接固体样品分析技术，用于确定具有稳定的放射性核磁共振能力（Tc-99m）和镭（Re-186，Re）的含硫螯合剂的冻干试剂盒中的含量和均匀性 -188）。 本文中使用经济，稳定且易于获得的煤标准作为对比物质来构建硫校准曲线，随后通过将上述结果内插到硫校准曲线中来获得固体冻干样品中的硫含量及其均匀性。 然后，将重量含量百分比转化为获得冻干试剂盒中螯合剂的含量和均匀性。 因此，确保了关键生产过程和临床应用中冻干试剂盒中活性药物成分（API）的质量控制。

    Measurement and calibration method for sample injection volume and mobile phase delivery rate in a ultra micro-scale liquid phase delivery system
    4.
    发明授权
    Measurement and calibration method for sample injection volume and mobile phase delivery rate in a ultra micro-scale liquid phase delivery system 失效
    超微量级液相输送系统中样品注入量和流动相输送速率的测量和校准方法

    公开(公告)号：US07638338B2

    公开(公告)日：2009-12-29

    申请号：US11119215

    申请日：2005-04-29

    申请人： Kung-Tien Liu ,  Jyh-Perng Chiu ,  Hsuan-Erh Chao ,  Ying-Kai Fu

    发明人： Kung-Tien Liu ,  Jyh-Perng Chiu ,  Hsuan-Erh Chao ,  Ying-Kai Fu

    IPC分类号： G01N33/00

    CPC分类号： G01F25/0092 ,  G01F1/7042 ,  G01N35/1016 ,  G01N2035/1034 ,  Y10T436/13

    摘要： The present invention provides a method for measuring and calibrating sample injection volume or mobile phase delivery rate of any type of micropumps or their integrated systems by using the direct proportion of the total activity (or mass) to the delivery rate (or volume) of a radiochemical nuclide with known activity in a certain time period. Also, the present invention may adjust the range of measurement and calibration from micro-liter (μL) to pico-liter (pL) or from μL/min to pL/min by selecting nuclide species and their concentrations from different liquid calibration radiation sources.

    摘要翻译： 本发明提供了一种用于通过使用总活度（或质量）与总活性（或​​体积）的直接比例相比，来测量和校准任何类型的微型泵或其集成系统的样品进样体积或流动相递送速率的方法， 放射化学核素在一定时间内具有已知活性。 此外，本发明可以通过从不同的液体校准辐射源中选择核素种类及其浓度，将测量和校准的范围从微升（μL）调整到微升（pL）或从muL / min调节到pL / min。

    Technology for the determination of impurities in TRODAT-1 raw material
    5.
    发明申请
    Technology for the determination of impurities in TRODAT-1 raw material 审中-公开
    用于测定TRODAT-1原料杂质的技术

    公开(公告)号：US20070042502A1

    公开(公告)日：2007-02-22

    申请号：US11161888

    申请日：2005-08-21

    申请人： Kung Tien Liu ,  Yi Chih Hsia ,  Chang Yung Su ,  Chiung Fang Huang ,  Ying Kai Fu

    发明人： Kung Tien Liu ,  Yi Chih Hsia ,  Chang Yung Su ,  Chiung Fang Huang ,  Ying Kai Fu

    IPC分类号： G01N30/02

    CPC分类号： G01N30/88 ,  G01N30/7233 ,  G01N2030/027 ,  G01N2030/8809 ,  Y10T436/25375

    摘要： This invention discloses a novel technology for the impurities assay of TRODAT-1 raw material by reverse phase high performance liquid chromatography (RP-HPLC). The method for TRODAT-1 raw material impurities assay of this present invention includes using high performance liquid chromatography (HPLC), liquid chromatography tandem mass spectrometry (LC-MS/MS), HPLC column, preparation of samples, regents and eluent as well as performing parent and product ion analysis by mass spectrometry for the method validation, calculation of chromatographic resolution and raw material impurities. This invention is the first report in the world that proved the existence of oligomers in TRODAT-1 raw material, as well as an analytical method through elaborated validation procedures to quantify the impurities (including the oligomers) in TRODAT-1 raw material.

    摘要翻译： 本发明公开了通过反相高效液相色谱（RP-HPLC）对TRODAT-1原料进行杂质测定的新技术。 本发明的TRODAT-1原料杂质测定方法包括使用高效液相色谱（HPLC），液相色谱串联质谱（LC-MS / MS），HPLC柱，样品制备，试剂和洗脱液以及 通过质谱法进行母体和产品离子分析，进行方法验证，计算色谱分离度和原料杂质。 本发明是世界上第一份证明TRODAT-1原料中低聚物存在的报告，以及通过详细验证程序对TRODAT-1原料中杂质（包括低聚物）进行定量的分析方法。

    Direct solid sample analytical technology for determining a content and a uniformity thereof in a lyophilized kit of a sulfur-containing chelator with a stable complex capacity for radiotechnetium (Tc-99M) and radiorhenium (Re-186, Re-188)
    6.
    发明授权
    Direct solid sample analytical technology for determining a content and a uniformity thereof in a lyophilized kit of a sulfur-containing chelator with a stable complex capacity for radiotechnetium (Tc-99M) and radiorhenium (Re-186, Re-188) 有权
    用于确定具有稳定的放射性核磁共振能力（Tc-99M）和镭（Re-186，Re-188）的含硫螯合剂的冻干试剂盒中的含量和均匀性的直接固体样品分析技术，

    公开(公告)号：US08831891B2

    公开(公告)日：2014-09-09

    申请号：US13273346

    申请日：2011-10-14

    申请人： Kung-Tien Liu ,  Ming-Yu Chao ,  Yi-Chih Hsia ,  Shih-Woei Yeh ,  Mei-Hsiu Liao ,  Lee-Chung Men ,  Lie-Hang Shen

    发明人： Kung-Tien Liu ,  Ming-Yu Chao ,  Yi-Chih Hsia ,  Shih-Woei Yeh ,  Mei-Hsiu Liao ,  Lee-Chung Men ,  Lie-Hang Shen

    IPC分类号： A61K51/04

    CPC分类号： A61K51/0478

    摘要： The present invention is related to a direct solid sample analytical technology for determining a content and a uniformity thereof in a lyophilized kit of a sulfur-containing chelator with a stable complex capacity for radiotechnetium (Tc-99m) and radiorhenium (Re-186, Re-188). An economical, stable and easily accessible coal standard is used herein as a contrast substance to construct a sulfur calibration curve, followed by obtaining the sulfur content and the uniformity thereof in the solid lyophilized sample by interpolating the foregoing result into the sulfur calibration curve. Then, the weight content percent is converted to get the content and the uniformity of the chelator in the lyophilized kit. The quality control of active pharmaceutical ingredients (API) in the lyophilized kit during key production processes and clinical applications is thus assured.

    摘要翻译： 本发明涉及一种直接固体样品分析技术，用于确定具有稳定的放射性核磁共振能力（Tc-99m）和镭（Re-186，Re）的含硫螯合剂的冻干试剂盒中的含量和均匀性 -188）。 本文中使用经济，稳定且易于获得的煤标准作为对比物质来构建硫校准曲线，随后通过将上述结果内插到硫校准曲线中来获得固体冻干样品中的硫含量及其均匀性。 然后，将重量含量百分比转化为获得冻干试剂盒中螯合剂的含量和均匀性。 因此，确保了关键生产过程和临床应用中冻干试剂盒中活性药物成分（API）的质量控制。

    A novel technology for the purity assay of TRODAT-1 raw material
    9.
    发明申请
    A novel technology for the purity assay of TRODAT-1 raw material 审中-公开
    一种用于TRODAT-1原料纯度测定的新技术

    公开(公告)号：US20070042501A1

    公开(公告)日：2007-02-22

    申请号：US11161883

    申请日：2005-08-20

    申请人： Kung Tien Liu ,  Yi Chih Hsia ,  Chung Yung Su ,  Chiung Fang Huang ,  Ying Kai Fu

    发明人： Kung Tien Liu ,  Yi Chih Hsia ,  Chung Yung Su ,  Chiung Fang Huang ,  Ying Kai Fu

    IPC分类号： G01N30/02

    CPC分类号： G01N30/88 ,  G01N2030/8809 ,  Y10T436/25375

    摘要： This invention discloses a novel technology for the purity assay of TRODAT-1 raw material by reverse phase high performance liquid chromatography (RP-HPLC). The method for TRODAT-1 raw material purity assay of this present invention includes using high performance liquid chromatography (HPLC), liquid chromatography tandem mass spectrometry (LC-MS/MS), HPLC column, preparation of samples, regents and eluent as well as performing parent and product ion analysis by mass spectrometry for the method validation, calculation of chromatographic resolutions and raw material purity. This invention discloses the first in the world of purity assay for TRODAT-1 raw material through elaborated validation procedures.

    摘要翻译： 本发明公开了通过反相高效液相色谱（RP-HPLC）对TRODAT-1原料的纯度测定的新技术。 本发明的TRODAT-1原料纯度测定方法包括使用高效液相色谱（HPLC），液相色谱串联质谱（LC-MS / MS），HPLC柱，样品制备，试剂和洗脱液以及 通过质谱法进行母体和产品离子分析，方法验证，色谱分辨率计算和原料纯度。 本发明通过详细的验证程序公开了TRODAT-1原料纯度测定世界第一。