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[ TECHNOLOGY BRIEF ]Use of a Proprietary Polar Column Chemistry for the Separationof Nitrosamines in Sartan and Ranitidine Drug SubstancesMargaret Maziarz, Sherri Naughton, and Paul RainvilleWaters Corporation, Milford, MA, USAThe XSelect HSS T3 Column enables reliableseparation of nitrosamine impurities in...
Key words
ranitidine, ranitidineimpurities, impuritiesrecalls, recallsbrief, briefarb, arbnitrosamine, nitrosaminephotodiode, photodiodecarcinogenic, carcinogenictechnology, technologynitrosamines, nitrosaminesdrug, drugalertingpatients, alertingpatientsndmafound, ndmafoundnitrosoethyl, nitrosoethylproprietary
[ TECHNOLOGY BRIEF ]Reliable HPLC/UV Quantification of Nitrosamine Impuritiesin Valsartan and Ranitidine Drug SubstancesMargaret Maziarz and Paul RainvilleWaters Corporation, Milford, MA, USAThe ACQUITY Arc System with PDA Detector, integratedwith an ACQUITY QDa Mass Detector for accurate massconfirmation, enables reliable quantification...
Key words
nitrosamine, nitrosaminevalsartan, valsartanqda, qdaranitidine, ranitidineloq, loqimpurities, impuritiesmin, minndma, ndmaacquity, acquitynmba, nmbabrief, briefneipa, neipandipa, ndipadrug, drugreliable
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
[ APPLICATION NOTEBOOK ]IMPURITIESDeveloping Safe and Effective Drugs INT RODUCTIONNAVIGATIONT he pharmaceutical industry is integral in maintaining public health byproviding therapeutic and preventative medicines. T he cornerstones ofbringing new medicines to market are quality, safety, and efficacy. T heseattributes are controlled...
Key words
home, homeuplc, uplcimpurities, impuritiesusp, uspziprasidone, ziprasidoneacquity, acquityimpurity, impuritymethod, methodminutes, minutestioconazole, tioconazolesimvastatin, simvastatinhplc, hplcusing, usingrelated, relatedanalysis
 

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[ TECHNOLOGY BRIEF ]Use of a Proprietary Polar Column Chemistry for the Separationof Nitrosamines in Sartan and Ranitidine Drug SubstancesMargaret Maziarz, Sherri Naughton, and Paul RainvilleWaters Corporation, Milford, MA, USAThe XSelect HSS T3 Column enables reliableseparation of nitrosamine impurities in...
Key words
ranitidine, ranitidineimpurities, impuritiesrecalls, recallsbrief, briefarb, arbnitrosamine, nitrosaminephotodiode, photodiodecarcinogenic, carcinogenictechnology, technologynitrosamines, nitrosaminesdrug, drugalertingpatients, alertingpatientsndmafound, ndmafoundnitrosoethyl, nitrosoethylproprietary
[ TECHNOLOGY BRIEF ]Reliable HPLC/UV Quantification of Nitrosamine Impuritiesin Valsartan and Ranitidine Drug SubstancesMargaret Maziarz and Paul RainvilleWaters Corporation, Milford, MA, USAThe ACQUITY Arc System with PDA Detector, integratedwith an ACQUITY QDa Mass Detector for accurate massconfirmation, enables reliable quantification...
Key words
nitrosamine, nitrosaminevalsartan, valsartanqda, qdaranitidine, ranitidineloq, loqimpurities, impuritiesmin, minndma, ndmaacquity, acquitynmba, nmbabrief, briefneipa, neipandipa, ndipadrug, drugreliable
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
[ APPLICATION NOTEBOOK ]IMPURITIESDeveloping Safe and Effective Drugs INT RODUCTIONNAVIGATIONT he pharmaceutical industry is integral in maintaining public health byproviding therapeutic and preventative medicines. T he cornerstones ofbringing new medicines to market are quality, safety, and efficacy. T heseattributes are controlled...
Key words
home, homeuplc, uplcimpurities, impuritiesusp, uspziprasidone, ziprasidoneacquity, acquityimpurity, impuritymethod, methodminutes, minutestioconazole, tioconazolesimvastatin, simvastatinhplc, hplcusing, usingrelated, relatedanalysis
 

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