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In this application note, a method for the quantification of mutagenic Nitrosamine drug substance related impurity is described.
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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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.
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.
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) |
|---|---|
| Korean (Korea) | Complete (PDF) |
本文介紹了采用配置 APCI 源的 Agilent 6470 三重四極桿液質(zhì)聯(lián)用系統(tǒng)，同時(shí)檢測(cè)沙坦藥物中六種亞硝胺類基因毒性雜質(zhì) NDMA、NDEA、NMBA、NEIPA、NDIPA 和 NDBA 的方法。
本文介紹了采用 Agilent Ultivo 三重四極桿液質(zhì)聯(lián)用系統(tǒng)檢測(cè)氯沙坦鉀中的亞硝胺類雜質(zhì) NMBA 的方法。該方法采用常規(guī) ESI 源，即可獲得滿足檢測(cè)要求的分析結(jié)果，且方法簡(jiǎn)單、特異性高、靈敏度高，大大優(yōu)于 FDA 官網(wǎng)公布的限量要求。