Determination of Nitrosamine Impurities in Losartan Potassium Drug Substance Using Triple Quadrupole LC-MS
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Nitrosamine impurities are byproducts produced in trace amounts during the manufacturing processes of angiotensin receptor blocking (ARB) medications. However, these impurities are classified as probable carcinogens, and so their discovery in and consequent recall of ARB drugs such as Losartan made N-Nitroso impurities a focus for many regulatory agencies.
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