CN110441460A - 一种伏立康唑中微量基因毒性杂质检测方法 - Google Patents
一种伏立康唑中微量基因毒性杂质检测方法 Download PDFInfo
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- CN110441460A CN110441460A CN201910865742.3A CN201910865742A CN110441460A CN 110441460 A CN110441460 A CN 110441460A CN 201910865742 A CN201910865742 A CN 201910865742A CN 110441460 A CN110441460 A CN 110441460A
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- voriconazole
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
- G01N2030/067—Preparation by reaction, e.g. derivatising the sample
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
- G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
- G01N2030/8872—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample impurities
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- Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
Description
时间(min) | 流动相A(%) | 流动相B(%) |
0 | 80 | 20 |
10~25 | 20 | 80 |
25~33 | 10 | 90 |
33~35 | 10 | 90 |
35~40 | 80 | 20 |
40 | 80 | 20 |
溶液名称 | 进样针数 |
空白溶液 | 至少2针 |
对照溶液 | 5针 |
供试品溶液 | 2针 |
加标供试品溶液 | 2针 |
对照溶液 | 1针 |
空白溶液 | 对照溶液 | 供试品溶液 | 加标供试品溶液 | |
保留时间/min | / | 29.268 | / | 29.278 |
峰面积 | / | 12925 | / | 12283 |
Claims (10)
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN114544843A (zh) * | 2020-11-25 | 2022-05-27 | 珠海润都制药股份有限公司 | 一种伏立康唑中4-(1-溴代乙基)-5-氟-6-氯嘧啶的检测方法 |
CN115856144A (zh) * | 2022-12-19 | 2023-03-28 | 华夏生生药业(北京)有限公司 | 一种氟康唑原料药及注射液中三甲基碘化亚砜杂质的检测方法 |
CN116106434A (zh) * | 2022-03-17 | 2023-05-12 | 南京易亨制药有限公司 | 高效检测4-氯-6-乙基-5-氟嘧啶中有关物质的方法 |
Citations (4)
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CN103896855A (zh) * | 2014-03-17 | 2014-07-02 | 巨化集团技术中心 | 一种4-(1-溴代乙基)-5-氟-6-氯嘧啶的合成方法 |
CN105699498A (zh) * | 2014-11-25 | 2016-06-22 | 陕西合成药业股份有限公司 | 一种分离分析伏立康唑前药有关物质的hplc方法 |
CN108051528A (zh) * | 2018-02-05 | 2018-05-18 | 成都倍特药业有限公司 | 从药物中检测樟脑磺酸酯类化合物的方法 |
CN109212048A (zh) * | 2017-07-07 | 2019-01-15 | 常州齐晖药业有限公司 | 一种伏立康唑中杂质含量的检测方法 |
-
2019
- 2019-09-12 CN CN201910865742.3A patent/CN110441460B/zh active Active
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
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CN103896855A (zh) * | 2014-03-17 | 2014-07-02 | 巨化集团技术中心 | 一种4-(1-溴代乙基)-5-氟-6-氯嘧啶的合成方法 |
CN105699498A (zh) * | 2014-11-25 | 2016-06-22 | 陕西合成药业股份有限公司 | 一种分离分析伏立康唑前药有关物质的hplc方法 |
CN109212048A (zh) * | 2017-07-07 | 2019-01-15 | 常州齐晖药业有限公司 | 一种伏立康唑中杂质含量的检测方法 |
CN108051528A (zh) * | 2018-02-05 | 2018-05-18 | 成都倍特药业有限公司 | 从药物中检测樟脑磺酸酯类化合物的方法 |
Non-Patent Citations (4)
Title |
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冯娇 等: "伏立康唑合成的起始原料质量控制研究", 《大家健康(学术版)》 * |
刘英莉 等: "衍生高效液相色谱法测定废水中芥子气研究", 《防化研究》 * |
浦锡娟: "RP-HPLC法测定注射用伏立康唑含量及其有关物质", 《现代医学》 * |
霍志铭 等: "1,2-苯二硫酚衍生-高效液相色谱法检测二硫代氨基甲酸酯类化合物的方法改进", 《农药学学报》 * |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN114544843A (zh) * | 2020-11-25 | 2022-05-27 | 珠海润都制药股份有限公司 | 一种伏立康唑中4-(1-溴代乙基)-5-氟-6-氯嘧啶的检测方法 |
CN114544843B (zh) * | 2020-11-25 | 2023-05-02 | 珠海润都制药股份有限公司 | 一种伏立康唑中4-(1-溴代乙基)-5-氟-6-氯嘧啶的检测方法 |
CN116106434A (zh) * | 2022-03-17 | 2023-05-12 | 南京易亨制药有限公司 | 高效检测4-氯-6-乙基-5-氟嘧啶中有关物质的方法 |
CN115856144A (zh) * | 2022-12-19 | 2023-03-28 | 华夏生生药业(北京)有限公司 | 一种氟康唑原料药及注射液中三甲基碘化亚砜杂质的检测方法 |
CN115856144B (zh) * | 2022-12-19 | 2023-07-07 | 华夏生生药业(北京)有限公司 | 一种氟康唑原料药及注射液中三甲基碘化亚砜杂质的检测方法 |
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Address after: 430075 Wuhan Donghu New Technology Development Zone High-tech Road 666 Wuhan National Biological Industry Base Project B, C, D R&D Building B1 (R&D zone C2-2) Patentee after: WUHAN LL SCIENCE AND TECHNOLOGY DEVELOPMENT Co.,Ltd. Patentee after: Wuhan Ruisheng Pharmaceutical Co.,Ltd. Patentee after: WUHAN QR PHARMACEUTICALS Co.,Ltd. Address before: 430075 Wuhan Donghu New Technology Development Zone High-tech Road 666 Wuhan National Biological Industry Base Project B, C, D R&D Building B1 (R&D zone C2-2) Patentee before: WUHAN LL SCIENCE AND TECHNOLOGY DEVELOPMENT Co.,Ltd. Patentee before: WUHAN ZHONGYOU PHARMACEUTICAL Co.,Ltd. Patentee before: WUHAN QR PHARMACEUTICALS Co.,Ltd. |
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Effective date of registration: 20230428 Address after: 436070 No. 28, Chuangye Avenue, Gedian Development Zone, Ezhou City, Hubei Province Patentee after: Wuhan Ruisheng Pharmaceutical Co.,Ltd. Patentee after: WUHAN QR PHARMACEUTICALS Co.,Ltd. Address before: 430075 Wuhan Donghu New Technology Development Zone High-tech Road 666 Wuhan National Biological Industry Base Project B, C, D R&D Building B1 (R&D zone C2-2) Patentee before: WUHAN LL SCIENCE AND TECHNOLOGY DEVELOPMENT Co.,Ltd. Patentee before: Wuhan Ruisheng Pharmaceutical Co.,Ltd. Patentee before: WUHAN QR PHARMACEUTICALS Co.,Ltd. |
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