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Learn about proven workflows for regulatory compliance, enhance drug quality and safety, simplify analysis with cutting-edge technology.
| Chinese (Simplified) (China) | Complete (PDF) |
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In this application note, a method for the quantification of mutagenic Nitrosamine drug substance related impurity is described.
| Chinese (Simplified) (China) | Complete (PDF) |
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| Korean (Korea) | Complete (PDF) |
| Japanese (Japan) | Complete (PDF) |
In this application note, a method for the simultaneous quantitation of four impurities in Clozapine API using the Agilent 6470 Triple Quadrupole LC/MS is described, with particular attention to quality of separation.
Consumables workflow ordering guide for nitrosamines analysis in pharmaceuticals using single quadrupole GC/MS or triple quadrupole GC/MS.
| Italian (Italy) | Complete (PDF) |
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| Spanish (Spain) | Complete (PDF) |
| French (France) | Complete (PDF) |
| Japanese (Japan) | Complete (PDF) |
| Russian (Russia) | Complete (PDF) |
| German (Germany) | Complete (PDF) |
| Chinese (Simplified) (China) | Complete (PDF) |
Consumables workflow ordering guide for nitrosamines analysis in pharmaceuticals using Triple Quadrupole LC/MS/MS and Quadrupole Time of Flight LC/MS.
| Chinese (Simplified) (China) | Complete (PDF) |
|---|---|
| Portuguese (Brazil) | Complete (PDF) |
| Japanese (Japan) | Complete (PDF) |
| Russian (Russia) | Complete (PDF) |
| German (Germany) | Complete (PDF) |
| French (France) | Complete (PDF) |
| Spanish (Spain) | Complete (PDF) |
| Italian (Italy) | Complete (PDF) |
A method describing the detection of 12 potentially mutagenic nitrosamine impurities found in sartan drugs using the Ultivo LC/TQ
| Chinese (Simplified) (China) | Complete (PDF) |
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Sensitive, high-resolution LC/MS/MS method using the Agilent 6546 LC/Q-TOF for the detection and quantification of the nitrosamine impurities
A LC/MS/MS based method for the quantitation of ‘N-nitroso Bumetanide impurity’ in Bumetanide API and low dose tablets.
A highly sensitive LC/MS/MS method for the simultaneous determination of eight nitrosamine impurities in metformin drug substance and drug products.
GC/MS and GC/MS/MS systems offer a complete solution for the determination and estimation of five nitrosamine impurities.
Comprehensive application guide by drug for the analysis of nitrosamine impurities in pharmaceuticals
In this application note, we have developed a highly sensitive triple quadrupole-based LC/MS/MS method for the simultaneous determination of eight nitrosamine impurities in metformin drug substance.
Analysis of five nitrosamines in sartan drugs using the published GC-MS/MS FDA method
| Chinese (Simplified) (China) | Complete (PDF) |
|---|---|
| Korean (Korea) | Complete (PDF) |
| Japanese (Japan) | Complete (PDF) |
Describes the use of the Agilent 8890 GC to analyze impurities in sartan products according to a United States Food and Drug Administration (US FDA) method.
This application note describes an LC/MS/MS method using the Agilent 6470A triple quadrupole LC/MS for the detection and quantification of NDMA in ranitidine drug substances and products.
| Chinese (Simplified) (China) | Complete (PDF) |
|---|---|
| Japanese (Japan) | Complete (PDF) |
| Korean (Korea) | Complete (PDF) |
This application note describes a sensitive, high-resolution LC/MS/MS method using the 6546 LC/Q-TOF for the detection and quantification of NDMA in ranitidine drug substance and products.
| Chinese (Simplified) (China) | Complete (PDF) |
|---|---|
| Korean (Korea) | Complete (PDF) |
| Japanese (Japan) | Complete (PDF) |
本應(yīng)用簡(jiǎn)報(bào)介紹了采用 Agilent 6470 三重四極桿液質(zhì)聯(lián)用系統(tǒng)檢測(cè)替丁類藥物中的 N-亞硝基二甲胺 (NDMA) 的方法。該方法可以有效避免替丁類藥物受熱不穩(wěn)定而分解出亞硝胺的問題，檢測(cè)結(jié)果準(zhǔn)確、重現(xiàn)性好、特異性強(qiáng)，且靈敏度優(yōu)于 NDMA 目前的法規(guī)限量要求（96 ng/天）。該方法適用于對(duì)...
本應(yīng)用報(bào)告介紹了采用 Agilent 6470 三重四極桿液質(zhì)聯(lián)用系統(tǒng)檢測(cè)二甲雙胍及相關(guān)制劑中的 N-亞硝基二甲胺 (NDMA) 的方法。該方法采用常規(guī)反相體系，重現(xiàn)性好、特異性強(qiáng)，且靈敏度優(yōu)于目前的 NDMA 法規(guī)限量要求（96 ng/天），適用于對(duì)二甲雙胍原料藥及市面所見的二甲雙胍類制劑中的 N...