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LC-MRM-MS Method for the Detection and Quantification of Six Nitrosamine Impurities in Sartan (ARBs) Drugs
Here, we present LC-MS methods capable of detecting highly polar nitrosamines at 0.007 ppm in the drug product, which is lower than the specification limit for NDMA. Three different stationary phases, a highly inert pentafluoro phenyl, an aqueous stable biphenyl, and a Polar C18 phase capable of providing excellent retention of polar nitrosamines with good peak shape were used for this purpose.

LC-MRM-MS Method for the Detection and Quantification of Six Nitrosamine Impurities in Sartan (ARBs) Drugs

Here, we present LC-MS methods capable of detecting highly polar nitrosamines at 0.007 ppm in the drug product, which is lower than the specification limit for NDMA. Three different stationary phases, a highly inert pentafluoro phenyl, an aqueous stable biphenyl, and a Polar C18 phase capable of providing excellent retention of polar nitrosamines with good peak shape were used for this purpose.
Document Type:
Poster
Target Industries:
Techniques:
Separation Modes:
Reversed Phase