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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...
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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
Nitrosamine ImpuritiesApplication GuideConfidently Detect and QuantifyMutagenic Impurities in APIs andDrug Products Sartan-BasedLosartan ValsartanCandesartan TelmisartanMetforminRanitidineNitrosamines are formed by chemical reactions that occur during APImanufacturing whether from starting materials, intermediates, reactants, reuse ofsolvents and by-products; they can form through degradation products generatedduring formulation...
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back, backndma, ndmaneipa, neipafda, fdandipa, ndipandea, ndeandba, ndbametformin, metforminnitrosamine, nitrosamineintroduction, introductionapi, apibest, bestvalsartan, valsartancandesartan, candesartantelmisartan
High Sensitivity Quantitation of Nitrosamine Genotoxic Impurities:LC-MS Analysis of Ranitidine Drug Product using the Waters ACQUITYUPLC I-Class/Xevo TQ-XS Tandem Quadrupole Mass SpectrometerMary Trudeau Lame and Lindsay HatchWaters Corporation, Milford, MA, USAAPPLICATION BENEFITS■■A simple and reproducible method forRanitidine is a histamine-2...
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ndma, ndmaranitidine, ranitidinenitrosamine, nitrosaminedrug, drugnmba, nmbablank, blankndba, ndbandea, ndeandipa, ndipaproduct, productarea, areaxevo, xevoneipa, neipaimpurities, impuritiesuplc
 

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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
Nitrosamine ImpuritiesApplication GuideConfidently Detect and QuantifyMutagenic Impurities in APIs andDrug Products Sartan-BasedLosartan ValsartanCandesartan TelmisartanMetforminRanitidineNitrosamines are formed by chemical reactions that occur during APImanufacturing whether from starting materials, intermediates, reactants, reuse ofsolvents and by-products; they can form through degradation products generatedduring formulation...
Key words
back, backndma, ndmaneipa, neipafda, fdandipa, ndipandea, ndeandba, ndbametformin, metforminnitrosamine, nitrosamineintroduction, introductionapi, apibest, bestvalsartan, valsartancandesartan, candesartantelmisartan
High Sensitivity Quantitation of Nitrosamine Genotoxic Impurities:LC-MS Analysis of Ranitidine Drug Product using the Waters ACQUITYUPLC I-Class/Xevo TQ-XS Tandem Quadrupole Mass SpectrometerMary Trudeau Lame and Lindsay HatchWaters Corporation, Milford, MA, USAAPPLICATION BENEFITS■■A simple and reproducible method forRanitidine is a histamine-2...
Key words
ndma, ndmaranitidine, ranitidinenitrosamine, nitrosaminedrug, drugnmba, nmbablank, blankndba, ndbandea, ndeandipa, ndipaproduct, productarea, areaxevo, xevoneipa, neipaimpurities, impuritiesuplc
 

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