High Sensitivity Quantitation of Nitrosamine Genotoxic Impurities: LC-MS Analysis of Ranitidine Drug Product using the Waters ACQUITY UPLC I-Class/Xevo TQ-XS Tandem Quadrupole Mass SpectrometerApplications | 2020 | WatersInstrumentation
LC/MS, LC/MS/MS, LC/QQQ
Industries
Pharma & Biopharma
Manufacturer
Waters
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Highly Sensitive and Robust UPLC-MS/MS Quantification ofNitrosamine Impurities in Sartan and Ranitidine Drug SubstancesMary Trudeau Lame , Lindsay Hatch, Dave Higton, Paul Rainville, and Gordon FujimotoWaters Corporation, Milford, MA, USA2. UPLC Chromatographic Separation of NitrosamineImpurities and Ranitidine/’Sartan APIIntroduction4. Detection and...
Key words
blank, blankranitidine, ranitidinendma, ndmadrug, drugndea, ndeamilford, milfordgti, gtisartan, sartanneipa, neipandipa, ndipandba, ndbanitrosamine, nitrosamineimpurities, impuritiesformulation, formulationrobust
[ TECHNOLOGY BRIEF ]Highly Sensitive and Robust UPLC-MS/MS Quantification ofNitrosamine Impurities in Sartan and Ranitidine Drug SubstancesLindsay Hatch, Mary Lame, Dave Higton, Paul Rainville, and Gordon FujimotoWaters Corporation, Milford, MA, USAThe Xevo TQ-XS Mass Spectrometer, coupled to anACQUITY UPLC I-Class...
Key words
nitrosamine, nitrosamineranitidine, ranitidinenmba, nmbaneipa, neipandma, ndmandipa, ndipaimpurities, impuritiesndba, ndbandea, ndeadrug, drugquantification, quantificationblank, blanksix, sixnitrosamines, nitrosaminesrecalls
Application NotePharmaceuticalsDetermination of NitrosamineImpurities Using the Ultivo TripleQuadrupole LC/MSDetection of regulated genotoxic impurities from thedrug manufacturing processAuthorsChander Mani andSaikat BanerjeeAgilent Technologies, Inc.AbstractRecent findings show that some Angiotensin II receptor blocker (ARB) drugproducts contain carcinogenic nitrosamine impurities.1 As a result, many...
Key words
nmipa, nmipanmpha, nmphanmba, nmbaneipa, neipaethylnitrosamine, ethylnitrosaminendipa, ndipandba, ndbandea, ndeanmea, nmeanpyr, npyrnpip, npipndma, ndmaultivo, ultivonitrosamine, nitrosamineaverage
Poster ReprintASMS 2020WP 555Determination of Nitrosamineimpurities in Losartan Potassiumdrug substance using TripleQuadrupole LiquidChromatography MassSpectrometryChander Mani ,Saikat Banerjee and SamirVyas(Agilent Technologies, India.) IntroductionThe announcement for the recall of ARB medicinesValsartan, Losartan and Irbesartan made N-Nitrosoimpurities a focus for regulatory agencies includingthe FDA...
Key words
losartan, losartannmba, nmbanitrosamine, nitrosamineneipa, neipandipa, ndipapotassium, potassiumndba, ndbandea, ndeandma, ndmaimpurities, impuritiessubstance, substancedrug, drugapci, apcirecovery, recoverymethod

High Sensitivity Quantitation of Nitrosamine Genotoxic Impurities: LC-MS Analysis of Ranitidine Drug Product using the Waters ACQUITY UPLC I-Class/Xevo TQ-XS Tandem Quadrupole Mass SpectrometerApplications | 2020 | WatersInstrumentation
LC/MS, LC/MS/MS, LC/QQQ
Industries
Pharma & Biopharma
Manufacturer
Waters
Key words

 

Similar PDF

Toggle
Highly Sensitive and Robust UPLC-MS/MS Quantification ofNitrosamine Impurities in Sartan and Ranitidine Drug SubstancesMary Trudeau Lame , Lindsay Hatch, Dave Higton, Paul Rainville, and Gordon FujimotoWaters Corporation, Milford, MA, USA2. UPLC Chromatographic Separation of NitrosamineImpurities and Ranitidine/’Sartan APIIntroduction4. Detection and...
Key words
blank, blankranitidine, ranitidinendma, ndmadrug, drugndea, ndeamilford, milfordgti, gtisartan, sartanneipa, neipandipa, ndipandba, ndbanitrosamine, nitrosamineimpurities, impuritiesformulation, formulationrobust
[ TECHNOLOGY BRIEF ]Highly Sensitive and Robust UPLC-MS/MS Quantification ofNitrosamine Impurities in Sartan and Ranitidine Drug SubstancesLindsay Hatch, Mary Lame, Dave Higton, Paul Rainville, and Gordon FujimotoWaters Corporation, Milford, MA, USAThe Xevo TQ-XS Mass Spectrometer, coupled to anACQUITY UPLC I-Class...
Key words
nitrosamine, nitrosamineranitidine, ranitidinenmba, nmbaneipa, neipandma, ndmandipa, ndipaimpurities, impuritiesndba, ndbandea, ndeadrug, drugquantification, quantificationblank, blanksix, sixnitrosamines, nitrosaminesrecalls
Application NotePharmaceuticalsDetermination of NitrosamineImpurities Using the Ultivo TripleQuadrupole LC/MSDetection of regulated genotoxic impurities from thedrug manufacturing processAuthorsChander Mani andSaikat BanerjeeAgilent Technologies, Inc.AbstractRecent findings show that some Angiotensin II receptor blocker (ARB) drugproducts contain carcinogenic nitrosamine impurities.1 As a result, many...
Key words
nmipa, nmipanmpha, nmphanmba, nmbaneipa, neipaethylnitrosamine, ethylnitrosaminendipa, ndipandba, ndbandea, ndeanmea, nmeanpyr, npyrnpip, npipndma, ndmaultivo, ultivonitrosamine, nitrosamineaverage
Poster ReprintASMS 2020WP 555Determination of Nitrosamineimpurities in Losartan Potassiumdrug substance using TripleQuadrupole LiquidChromatography MassSpectrometryChander Mani ,Saikat Banerjee and SamirVyas(Agilent Technologies, India.) IntroductionThe announcement for the recall of ARB medicinesValsartan, Losartan and Irbesartan made N-Nitrosoimpurities a focus for regulatory agencies includingthe FDA...
Key words
losartan, losartannmba, nmbanitrosamine, nitrosamineneipa, neipandipa, ndipapotassium, potassiumndba, ndbandea, ndeandma, ndmaimpurities, impuritiessubstance, substancedrug, drugapci, apcirecovery, recoverymethod
 

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