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Sensitive and reproducible LC-MS/MS based quantification method for NDMA in ranitidine API and drug products

 

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Analysis of Genotoxic Nitrosamines in Losartan and Ranitidine Active Pharmaceutical Ingredients On the SCIEX QTRAP® 4500 LC-MS/MS System with ExionLC™ AD System Sandeep Choudhary, Aman Sharma, M Chandrasekar, Manoj Pillai SCIEX, India In recent years, there have been several high…
Key words
losartan, losartanranitidine, ranitidinenitrosamine, nitrosaminendma, ndmagenotoxic, genotoxicavg, avgnitrosamines, nitrosamineslloq, lloqcompounds, compounds𝑎𝑙𝑙𝑜𝑤𝑒𝑑, 𝑎𝑙𝑙𝑜𝑤𝑒𝑑𝑑𝑎𝑖𝑙𝑦, 𝑑𝑎𝑖𝑙𝑦𝑑𝑜𝑠𝑒, 𝑑𝑜𝑠𝑒𝑒𝑥𝑝𝑜𝑠𝑢𝑟𝑒, 𝑒𝑥𝑝𝑜𝑠𝑢𝑟𝑒𝑚𝑒𝑑𝑖𝑐𝑎𝑡𝑖𝑜𝑛, 𝑚𝑒𝑑𝑖𝑐𝑎𝑡𝑖𝑜𝑛𝑛𝑖𝑡𝑟𝑜𝑠𝑎𝑚𝑖𝑛𝑒
Quantify NDMA using the SCIEX QTRAP® 4500 LC-MS/MS System N-Nitrosodimethylamine (NDMA) Analysis in Ranitidine Active Pharmaceutical Ingredient and Drug Product Using QTRAP® 4500 System The presence of nitrosamines, especially NDMA, has been identified in ranitidine drug products by the United…
Key words
ndma, ndmaranitidine, ranitidinespiked, spikedprove, provenitrosodimethylamine, nitrosodimethylaminelloq, lloqspec, specconcentration, concentrationlod, lodregulatory, regulatoryquantify, quantifystandard, standarduseful, usefulppm, ppmmuch
Highly Selective and Sensitive Method for Quantification of Nitrosamines in Valsartan Drug Substances Quantification using SCIEX Triple Quad™ 5500+ LC-MS/MS System − QTRAP® Ready with an ExionLC™ AD System Aman Sharma1, Sandeep Choudhary1, M Chandrasekar1, Manoj Pillai1 SCIEX, India Valsartan…
Key words
valsartan, valsartannitrosamine, nitrosaminesix, sixapi, apiaction, actionnmba, nmbaneipa, neipandipa, ndipandba, ndbandea, ndeandma, ndmalevels, levelsnitrosamines, nitrosaminesnitrosodiisoprpylamine, nitrosodiisoprpylaminenitrosomethylaminobutyric
Application Note No. 62 Analysis 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),…
Key words
ndma, ndmandea, ndeacarcinogenic, carcinogenicsubstances, substancesmutagenic, mutagenicmms, mmsimpurity, impurityems, emsmode, modeims, imsdrug, drugmutagenicity, mutagenicityolmesartan, olmesartanndba, ndbapharmaceuticals
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