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ApplicationNoteNo.62Analysis of Pharmaceuticals’ Impurity- Regulations and Analysis for Carcinogenic Substances Dheeraj Handique *a), Nitish Suryawanshi *a), Crystal Yeong *b), Cynthia Lahey *b), Shailendra Rane *a), Deepti Bhandarkar *a),Anant Lohar *a), Gao Jie san *c), Li Qiang *c), Fan Jun *c),...
Key words
ndma, ndmandea, ndeacarcinogenic, carcinogenicsubstances, substancesmutagenic, mutagenicmms, mmsimpurity, impuritymode, modeems, emsdrug, drugims, imsolmesartan, olmesartanmutagenicity, mutagenicityndba, ndbandipa
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, neipandipa, ndipaethylnitrosamine, ethylnitrosaminendba, ndbandea, ndeanmea, nmeanpyr, npyrnpip, npipndma, ndmanitrosamine, nitrosamineultivo, ultivoaverage
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, neipandipa, ndipafda, fdandea, ndeandba, ndbametformin, metforminnitrosamine, nitrosamineintroduction, introductionapi, apibest, bestcandesartan, candesartanvalsartan, valsartantelmisartan
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, areaneipa, neipaxevo, xevoimpurities, impuritiesuplc
 

Similar PDF

ApplicationNoteNo.62Analysis of Pharmaceuticals’ Impurity- Regulations and Analysis for Carcinogenic Substances Dheeraj Handique *a), Nitish Suryawanshi *a), Crystal Yeong *b), Cynthia Lahey *b), Shailendra Rane *a), Deepti Bhandarkar *a),Anant Lohar *a), Gao Jie san *c), Li Qiang *c), Fan Jun *c),...
Key words
ndma, ndmandea, ndeacarcinogenic, carcinogenicsubstances, substancesmutagenic, mutagenicmms, mmsimpurity, impuritymode, modeems, emsdrug, drugims, imsolmesartan, olmesartanmutagenicity, mutagenicityndba, ndbandipa
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, neipandipa, ndipaethylnitrosamine, ethylnitrosaminendba, ndbandea, ndeanmea, nmeanpyr, npyrnpip, npipndma, ndmanitrosamine, nitrosamineultivo, ultivoaverage
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, neipandipa, ndipafda, fdandea, ndeandba, ndbametformin, metforminnitrosamine, nitrosamineintroduction, introductionapi, apibest, bestcandesartan, candesartanvalsartan, valsartantelmisartan
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, areaneipa, neipaxevo, xevoimpurities, impuritiesuplc
 

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