• Ann Pharmacother · Jun 2020

    Editorial

    Understanding and Preventing (N-Nitrosodimethylamine) NDMA Contamination of Medications.

    • C Michael White.
    • University of Connecticut School of Pharmacy and Hartford Hospital, Storrs, CT, USA.
    • Ann Pharmacother. 2020 Jun 1; 54 (6): 611-614.

    AbstractN-nitrosodimethylamine (NDMA) is a hepatotoxic agent and carcinogen contaminant in commonly used medications such as valsartan, losartan, irbesartan, and ranitidine. NDMA can be produced during manufacture, introduced from contaminated ingredients procured elsewhere, or introduced from contaminated solvents and catalysts. The Food and Drug Administration has established a maximum dose of NDMA that is permissible per tablet and guidance for manufacturers. However, many unanswered questions about NDMA contamination need rigorous investigation.

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