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1. WO2021043117 - IMPURITY DETECTION METHOD FOR 2-((1S,2S,3R,6S,8S)-2-(AMINOMETHYL)TRICYCLO[4.2.1.0 3,8]NONANE-2-YL)ACETATE BENZENESULFONATE OR COMPOSITION THEREOF

Publication Number WO/2021/043117
Publication Date 11.03.2021
International Application No. PCT/CN2020/112764
International Filing Date 01.09.2020
IPC
G01N 30/02 2006.01
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
30Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography
02Column chromatography
C07C 229/28 2006.01
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
CACYCLIC OR CARBOCYCLIC COMPOUNDS
229Compounds containing amino and carboxyl groups bound to the same carbon skeleton
02having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton
28the carbon skeleton being saturated and containing rings
CPC
C07C 229/28
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
CACYCLIC OR CARBOCYCLIC COMPOUNDS
229Compounds containing amino and carboxyl groups bound to the same carbon skeleton
02having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton
28the carbon skeleton being saturated and containing rings
G01N 30/02
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
30Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography ; or field flow fractionation;
02Column chromatography
Applicants
  • 四川海思科制药有限公司 SICHUAN HAISCO PHARMACEUTICAL CO., LTD. [CN]/[CN]
Inventors
  • 邓娟娟 DENG, Juanjuan
  • 汪莉莉 WANG, Lili
  • 赵彩桂 ZHAO, Caigui
  • 彭田东 PENG, Tiandong
  • 严庞科 YAN, Pangke
Agents
  • 北京三友知识产权代理有限公司 BEIJING SANYOU INTELLECTUAL PROPERTY AGENCY LTD.
Priority Data
201910827651.003.09.2019CN
Publication Language Chinese (ZH)
Filing Language Chinese (ZH)
Designated States
Title
(EN) IMPURITY DETECTION METHOD FOR 2-((1S,2S,3R,6S,8S)-2-(AMINOMETHYL)TRICYCLO[4.2.1.0 3,8]NONANE-2-YL)ACETATE BENZENESULFONATE OR COMPOSITION THEREOF
(FR) PROCÉDÉ DE DÉTECTION D'IMPURETÉS D'ACÉTATE DE 2-((1S,2S,3R,6S,8S)-2-(AMINOMÉTHYL) TRICYCLO [4.2.1.0 3,8] NONANE-2-YL)-BENZÈNESULFONATE OU D'UNE COMPOSITION ASSOCIÉE
(ZH) 2-((1S,2S,3R,6S,8S)-2-(氨甲基)三环[4.2.1.03,8]壬烷-2-基)乙酸苯磺酸盐或其组合物杂质检测方法
Abstract
(EN)
Provided is a content, related substance and chiral isomer detection method for 2-((1S,2S,3R,6S,8S)-2-(aminomethyl)tricyclo[4.2.1.03,8]nonane-2-yl)acetate benzenesulfonate or a composition thereof. The content and related substance I are detected using a HPLC-CAD method, and related substance II and chiral isomers are detected using LC-MS. The present method can implement effective separation and quantitative detection of related substances I and II and chiral isomers from 2-((1S,2S,3R,6S,8S)-2-(aminomethyl)tricyclo[4.2.1.03,8]nonane-2-yl)acetate benzenesulfonate or a composition thereof, the degree of separation being greater than 1.5; specificity, repeatability, and stability are good, ensuring medicine quality and patient medication safety; and detection costs are greatly reduced, facilitating industrial production.
(FR)
L'invention concerne un procédé de détection de substances apparentées et de leur teneur, et d'isomères chiraux de l'acétate de 2-((1S,2S,3R,6S,8S)-2-(aminométhyl) tricyclo [4.2.1.03,8]nonane-2-yl)-benzènesulfonate ou d'une composition associée. La substance apparentée I et sa teneur sont détectées à l'aide d'un procédé HPLC-CAD, et la substance apparentée II et les isomères chiraux sont détectés à l'aide de LC-MS. Le présent procédé peut mettre en oeuvre une séparation efficace et une détection quantitative des substances apparentées I et II et d'isomères chiraux de l'acétate de 2-((1S,2S,3R,6S,8S)-2-(aminométhyl)) tricyclo [4.2.1.03,8]nonane-2-yle})-benzènesulfonate ou d'une composition correspondante, avec un degré de séparation supérieur à 1,5 ; la spécificité, la répétabilité et la stabilité du procédé sont bonnes, ce qui permet d'assurer une qualité de médicament et la sécurité de médication des patients ; et les coûts de détection sont considérablement réduits, ce qui facilite la production industrielle.
(ZH)
提供2-((1S,2S,3R,6S,8S)-2-(氨甲基)三环[4.2.1.0 3,8]壬烷-2-基)乙酸苯磺酸盐或其组合物的含量、有关物质及手性异构体检测方法。采用HPLC-CAD方法检测含量和有关物质Ⅰ,采用LC-MS检测有关物质Ⅱ和手性异构体。所述方法能实现2-((1S,2S,3R,6S,8S)-2-(氨甲基)三环[4.2.1.0 3,8]壬烷-2-基)乙酸苯磺酸盐或其组合物与有关物质Ⅰ、Ⅱ及其手性异构体的有效分离及定量检测,分离度大于1.5;专属性、重复性和稳定性好,保证了药物质量及患者用药安全;检测成本大大降低,有利于工业化生产。
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