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1. 发明申请

US20190194258A1 METHOD FOR CONTROLLING IMPURITY OF CYCLOSPORIN A EYE GEL 审中-公开
公开(公告)号：US20190194258A1
公开(公告)日：2019-06-27
申请号：US16228802
申请日：2018-12-21
申请人： ZHAOKE (GUANGZHOU) OPHTHALMIC DRUG COMPANY LIMITED
发明人： Gang Li , Kailei Cao , Xiaoyi Li , Xiangrong Dai , Lei Yin , Juan Ling
IPC分类号： C07K7/64 , C07K1/16 , B01D15/16 , B01D15/18 , B01D15/42 , B01J20/10
CPC分类号： C07K7/645 , B01D15/161 , B01D15/163 , B01D15/18 , B01D15/426 , B01J20/103 , B01J20/286 , B01J20/291 , B01J2220/58 , C07K1/16 , G01N30/30 , G01N30/88 , G01N2030/342 , G01N2030/8872
摘要： A method of controlling the impurities in a cyclosporin A eye gel. A high performance liquid chromatography is performed, and chromatographic conditions are as follows: the detection wavelength is 210-230 nm; the column temperature is 60-68° C.; the flow rate is 0.8-1 ml/min; and the mobile phase A is: THF-water-phosphoric acid. The method of controlling impurities solves the problem of excipients interference and separation of many impurities at the same time, it also provides an effective method for the formulation of quality standard of impurities in this kind of preparation.

2. 发明申请

US20180284077A1 METHODS FOR ANALYSIS AND RESOLUTION OF PREPARATIONS OF DIANHYDROGALACTITOL AND DERIVATIVES OR ANALOGS THEREOF 审中-公开
公开(公告)号：US20180284077A1
公开(公告)日：2018-10-04
申请号：US15778546
申请日：2016-11-22
申请人： Del Mar Pharmaceuticals (BC) Ltd.
发明人： Qiang Xu
IPC分类号： G01N30/22 , G01N30/88 , G01N30/74
CPC分类号： G01N30/22 , B01D15/305 , C07D303/14 , G01N30/30 , G01N30/34 , G01N30/7233 , G01N30/74 , G01N30/88 , G01N2030/027 , G01N2030/324 , G01N2030/8872
摘要： An improved analytical method for analysis of dianhydrogalactitol preparations provides a method for determining the purity of dianhydrogalactitol and detecting impurities in preparations of dianhydrogalactitol, as well as identifying any such impurities. The method employs high performance liquid chromatography (HPLC), in particular, HPLC employing a reverse phase amide column with ELSD detection; the HPLC can be followed by tandem mass spectroscopy. The method can further comprise the step of performing preparative HPLC collection of at least one specific substance peak present in a preparation of dianhydrogalactitol.

3. 发明申请

US20180086710A1 Determining Degradation of 3,4-Diaminopyridine 审中-公开
公开(公告)号：US20180086710A1
公开(公告)日：2018-03-29
申请号：US15695043
申请日：2017-09-05
申请人： Jacobus Pharmaceutical Company, Inc.
发明人： Guy Alan Schiehser , Rajendra Shah , Wenyi Zhao
IPC分类号： C07D213/73 , C07D401/04 , G01N30/74
CPC分类号： C07D213/73 , C07D401/04 , G01N30/74 , G01N2030/027 , G01N2030/884 , G01N2030/8872
摘要： The present invention relates to methods of determining the purity of a sample of 3,4-diaminopyridine comprising determining the presence, absence, or amount of a dimer of 3,4-diaminopyridine or a dimer of 3,4-diaminopyridine in the form of a salt, solvate or complex or a combination thereof. The invention also relates to methods of detecting and quantitating degradation in a sample of 3,4-diaminopyridine. Dimers of 3,4-diaminopyridine and methods of making and isolating the same are also provided.

4. 发明申请

US20150027206A1 ANALYTICAL METHODS FOR ANALYZING AND DETERMINING IMPURITIES IN DIANHYDROGALACTITOL 审中-公开
标题翻译：分析和测定二氢吡咯烷酮中的污染物的分析方法
公开(公告)号：US20150027206A1
公开(公告)日：2015-01-29
申请号：US14380924
申请日：2013-02-26
申请人： DEL MAR PHARMACEUTICALS
发明人： Xiaoyun Lu
IPC分类号： G01N30/88 , G01N33/15 , G01N30/06 , G01N30/72 , G01N30/74
CPC分类号： G01N30/88 , G01N21/49 , G01N30/06 , G01N30/7233 , G01N30/74 , G01N33/15 , G01N2030/027 , G01N2030/743 , G01N2030/8813 , G01N2030/8872 , Y10T436/142222 , Y10T436/203332
摘要： An improved analytical method for analysis of dianhydrogalactitol preparations provides a method for determining the purity of dianhydrogalactitol and detecting impurities in preparations of dianhydrogalactitol, as well as identifying any such impurities. The method employs high performance liquid chromatography (HPLC), in particular, HPLC with refractive index (RI) detection; the HPLC can be followed by tandem mass spectroscopy. The method can further comprise the step of performing preparative HPLC collection of at least one specific substance peak present in a preparation of dianhydrogalactitol.
摘要翻译：用于分析二缩水甘油醇制剂的改进的分析方法提供了测定二缩水甘油醇的纯度并检测二脱水半乳糖醇制剂中的杂质以及鉴定任何这些杂质的方法。该方法采用高效液相色谱（HPLC），特别是具有折射率（RI）检测的HPLC; HPLC后可以进行串联质谱。该方法还可以包括进行制备HPLC收集存在于二脱水半乳糖制剂中的至少一个特定物质峰的步骤。

5. 发明授权

US08562910B2 Method and apparatus for analysis of poly (biphenyl chloride) in electrical insulating oil 失效
标题翻译：电绝缘油中聚（联苯氯）的分析方法和装置
公开(公告)号：US08562910B2
公开(公告)日：2013-10-22
申请号：US12994300
申请日：2009-05-20
申请人： Masako Kawarai , Junkichi Miura , Tami Hiruta , Yoshinori Inoue
发明人： Masako Kawarai , Junkichi Miura , Tami Hiruta , Yoshinori Inoue
IPC分类号： G01N30/02
CPC分类号： G01N30/14 , G01N30/44 , G01N33/2835 , G01N2030/143 , G01N2030/8845 , G01N2030/8872
摘要： An object of the present invention is to provide a method and an apparatus by which PCBs in insulating oil can be analyzed with high accuracy in a convenient, inexpensive, and rapid manner. The method for analyzing polychlorobiphenyls by measuring the concentration of polychlorobiphenyls in insulating oil comprises a step of, as pretreatment, bringing particles of a copolymer that contains divinylbenzene and a methacrylate organic monomer as monomer components into contact with insulating oil containing polychlorobiphenyls, so as to separate polychlorobiphenyls in insulating oil from oil content that is an impurity. The methacrylate organic monomer preferably has a diol type hydroxyl group.
摘要翻译：本发明的目的是提供一种可以以便利，便宜和快速的方式以高精度分析绝缘油中的PCB的方法和装置。通过测定绝缘油中聚氯联苯的浓度来分析聚氯联苯的方法包括以下步骤：将包含二乙烯基苯和甲基丙烯酸酯有机单体的共聚物的颗粒作为预处理使含有聚氯代联苯的绝缘油接触，绝缘油中的聚氯联苯与杂质含油量。甲基丙烯酸酯有机单体优选具有二醇型羟基。

6. 发明申请

US20130074580A1 METHODS FOR QUANTITATING WATER USING IONIC LIQUID SALTS 有权
标题翻译：使用离子液体定量水的方法
公开(公告)号：US20130074580A1
公开(公告)日：2013-03-28
申请号：US13625659
申请日：2012-09-24
申请人： SIGMA-ALDRICH CO. LLC
发明人： Daniel W. Armstrong
IPC分类号： G01N1/22
CPC分类号： G01N30/62 , B01D53/02 , B01J20/288 , B01J20/29 , B01J20/3204 , B01J20/3253 , B01J20/3257 , B01J20/3282 , B01J20/3285 , B01J20/3287 , B01J2220/84 , B01J2220/86 , G01N1/22 , G01N2030/025 , G01N2030/8872
摘要： This disclosure provides methods and devices for quantitating, separating and/or detecting water in a liquid, gas or solid sample comprising one or more chemicals, the method comprising: providing the liquid, gas or solid sample comprising water and the one or more chemicals; and exposing said liquid, gas or solid sample to at least one solid support including at least one dicationic and/or tricationic species of Formula I or II adsorbed, absorbed or immobilized on the solid support.
摘要翻译：本公开提供了用于定量，分离和/或检测包含一种或多种化学品的液体，气体或固体样品中的水的方法和装置，所述方法包括：提供包含水和所述一种或多种化学品的液体，气体或固体样品; 以及将所述液体，气体或固体样品暴露于至少一种固体支持物，所述至少一种固体支持物包含吸收，吸收或固定在固体支持物上的式I或II的至少一种双阳离子和/或化合物种。

7. 发明授权

US08336371B2 Real-time, on-line analysis for the quantification of trihalomethane species within drinking water supplies 有权
标题翻译：实时，在线分析饮用水供应中三卤甲烷物质的量化
公开(公告)号：US08336371B2
公开(公告)日：2012-12-25
申请号：US12116943
申请日：2008-05-07
申请人： Gary Lynn Emmert , Michael Andrew Brown
发明人： Gary Lynn Emmert , Michael Andrew Brown
IPC分类号： G01N30/84
CPC分类号： G01N30/88 , C02F2209/29 , G01N2030/8845 , G01N2030/8872
摘要： Separating trihalomethanes from drinking water samples (via a process such as capillary membrane sampling, and the like) followed by gas chromatograph analysis to determine quantity measurements and species identification of such trihalomethane (THM4) contaminants therein is provided. With the necessity to chlorinate drinking water to remove harmful bacteria and other potential toxins, trihalomethane byproducts are generated that may harm humans after consumption as well due to suspect carcinogenicity of such compounds. A reliable manner of measuring such drinking water supplies for such THM4 contaminants at locations far from the source and closer to dispensers is highly desirable. The ability to separate the THM4 from the drinking water sample, followed by a gas chromatography or like manner of quantifying and identifying the THM4 compounds possibly present within the drinking water sample has been found to be nearly as reliable as federally mandated source measuring methods for the same purpose, but with the versatility to measure for such trihalomethane contaminants anywhere along the drinking water supply line.
摘要翻译：将三卤甲烷与饮用水样品（通过诸如毛细管膜取样等方法）分离，随后进行气相色谱分析，以确定其中的这种三卤甲烷（THM4）污染物的量测量和物种鉴定。由于需要对饮用水进行氯化除去有害细菌和其他潜在的毒素，因此产生三卤甲烷副产物，由于这些化合物的可疑致癌性，也可能对消费后的人造成危害。测量这样的饮用水的可靠方式是非常需要的，这种THM4污染物位于远离污染源并靠近分配器的地方。已经发现将THM4与饮用水样品分离的能力以及随后的气相色谱法或类似方式的量化和鉴定可能存在于饮用水样品中的THM4化合物几乎与联邦授权的源测量方法相当可靠同样的目的，但通过多功能性测量饮用水供应线上任何地方的这种三卤甲烷污染物。

8. 发明申请

US20090277255A1 Real-Time, On-Line Analysis for the Quantification of Trihalomethane Species Within Drinking Water Supplies 有权
标题翻译：饮用水中三卤甲烷物质定量的实时在线分析
公开(公告)号：US20090277255A1
公开(公告)日：2009-11-12
申请号：US12116943
申请日：2008-05-07
申请人： Gary Lynn Emmert , Michael Andrew Brown
发明人： Gary Lynn Emmert , Michael Andrew Brown
IPC分类号： G01N30/84
CPC分类号： G01N30/88 , C02F2209/29 , G01N2030/8845 , G01N2030/8872
摘要： Separating trihalomethanes from drinking water samples (via a process such as capillary membrane sampling, and the like) followed by gas chromatograph analysis to determine quantity measurements and species identification of such trihalomethane (THM4) contaminants therein is provided. With the necessity to chlorinate drinking water to remove harmful bacteria and other potential toxins, trihalomethane byproducts are generated that may harm humans after consumption as well due to suspect carcinogenicity of such compounds. A reliable manner of measuring such drinking water supplies for such THM4 contaminants at locations far from the source and closer to dispensers is highly desirable. The ability to separate the THM4 from the drinking water sample, followed by a gas chromatography or like manner of quantifying and identifying the THM4 compounds possibly present within the drinking water sample has been found to be nearly as reliable as federally mandated source measuring methods for the same purpose, but with the versatility to measure for such trihalomethane contaminants anywhere along the drinking water supply line.
摘要翻译：将三卤甲烷与饮用水样品（通过诸如毛细管膜取样等方法）分离，随后进行气相色谱分析，以确定其中的这种三卤甲烷（THM4）污染物的量测量和物种鉴定。由于需要对饮用水进行氯化除去有害细菌和其他潜在的毒素，因此产生三卤甲烷副产物，由于这些化合物的可疑致癌性，也可能对消费后的人造成危害。测量这样的饮用水的可靠方式是非常需要的，这种THM4污染物位于远离污染源并靠近分配器的地方。已经发现将THM4与饮用水样品分离的能力以及随后的气相色谱法或类似方式的量化和鉴定可能存在于饮用水样品中的THM4化合物几乎与联邦授权的源测量方法相当可靠同样的目的，但通过多功能性测量饮用水供应线上任何地方的这种三卤甲烷污染物。

9. 发明授权

US5679576A Gas chromatographic analysis of fluoromethyl-1,1,1,3,3,3-hexafluoroisopropyl ether 失效
标题翻译：氟甲基-1,1,1,3,3,3-六氟异丙醚的气相色谱分析
公开(公告)号：US5679576A
公开(公告)日：1997-10-21
申请号：US557016
申请日：1995-12-05
申请人： Toshikazu Kawai , Takaaki Yoshimura , Mineo Watanabe , Manami Kamakura
发明人： Toshikazu Kawai , Takaaki Yoshimura , Mineo Watanabe , Manami Kamakura
IPC分类号： G01N30/14 , C07C41/01 , C07C41/06 , C07C41/09 , C07C41/22 , C07C41/42 , C07C43/12 , G01N30/02 , G01N30/88
CPC分类号： C07C41/01 , C07C41/44 , G01N2030/025 , G01N2030/484 , G01N2030/8845 , G01N2030/8872 , Y10T436/12 , Y10T436/19 , Y10T436/196666
摘要： The present invention provides a method in which organic matter in the product accompanied with a non-reacted hydrogen fluoride can be handled without damaging the apparatus, using a cross-linked cyanopropylmethylphenylsilicone capillary column with which impurities of very small amounts can be separated, and with which non-reacted raw materials and by-products, which have a wide range of boiling points can be quantitated. The present invention further provides a process control method of a production method of fluoromethyl-1,1,1,3,3,3 -hexafluoroisopropyl ether, which is characterized in that the content of a particular component in one of the following steps is determined and in that, assuming this as a variable, the treatment condition of the step is adjusted: 1) a step of reacting together 1,1,1,3,3,3 -hexafluoroisopropyl alcohol, (para) formaldehyde, and hydrogen fluoride in the presence of sulfuric acid; 2) a step of contacting a crude fluoromethyl-1,1,1,3,3,3 -hexafluoroisopropyl ether with an alkali aqueous solution and/or water; and 3) a step of distilling crude fluoromethyl-1,1,1,3,3,3 -hexaflouroisopropyl ether
摘要翻译： PCT No.PCT / JP95 / 00538 Sec。 371 1995年12月5日第 102（e）日期1995年12月5日PCT 1995年3月23日PCT公布。 WO95 / 27898 PCT公开号日期1995年10月19日本发明提供了一种方法，其中可以处理伴随未反应的氟化氢的产物中的有机物质，而不会损坏设备，使用交联的氰基丙基甲基苯基硅氧烷毛细管柱，其中非常少量的杂质可以可以分离，并且可以定量具有广泛沸点的未反应的原料和副产物。本发明还提供了氟甲基-1,1,1,3,3,3-六氟异丙醚的制备方法的工艺控制方法，其特征在于确定以下步骤之一中的特定组分的含量并且将其作为变量，将步骤的处理条件进行调整：1）使1,1,1,3,3,3-六氟异丙醇，（对）甲醛和氟化氢反应的步骤存在硫酸; 2）使粗的氟甲基-1,1,1,3,3,3-六氟异丙醚与碱性水溶液和/或水接触的步骤; 和3）蒸馏粗制氟甲基-1,1,1,3,3,3-六氟丙基醚的步骤

10. 发明申请

US20190185505A1 PROCESS OF CONTROLLING THE IMPURITIES OF CLINDAMYCIN HYDROCHLORIDE 审中-公开
公开(公告)号：US20190185505A1
公开(公告)日：2019-06-20
申请号：US16219966
申请日：2018-12-14
申请人： ZHAOKE (GUANGZHOU) Ophthalmic Drug Company Limited
发明人： Dongsheng Ni , Jing Liu , Gang Li , Xiangrong Dai , Xiaoyi Li
IPC分类号： C07H15/16 , C07H1/06 , B01D15/14 , B01J20/10 , B01J20/28
CPC分类号： C07H15/16 , B01D15/14 , B01J20/103 , B01J20/2803 , B01J2220/54 , C07H1/06 , G01N30/34 , G01N30/36 , G01N30/60 , G01N30/88 , G01N2030/6013 , G01N2030/8872
摘要： The invention provides a process of controlling the impurities of clindamycin hydrochloride, comprising a step of purifying said clindamycin hydrochloride by two-phase high performance liquid chromatography, wherein the chromatographic conditions are as follows: the detection wavelength is 200-220 nm; the column temperature is 20-40° C.; the flow rate is 0.8-1 ml/min; Mobile phase A: 0.025 mol/L potassium dihydrogen phosphate solution; Mobile phase B: Acetonitrile; and gradient elution is performed. The method of controlling impurities of the invention can solve the problem of the interference by excipients and the problem of the separation of many impurities at the same time. It also provides an effective method for setting quality standard of impurities in such a formulation.

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