Page 55 - 2020Taiwan Food and Drug Administration Annual Report
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Pharmacopoeia (3) by referring to the information from the European Medicines Agency (EMA).
Subsequently, the manufacturers should conduct self-evaluation for other drugs and submit the
evaluation report to TFDA. In the future, for the control of nitrosamine impurities in various
drugs, TFDA will continue to track international information and update accordingly.
IV. Establish a method for quantitative analysis of nitrosamine impurities in
sartans drugs
TFDA quickly established a quantitative analysis with LC-MS/MS (Figure 3-8) for NDMA,
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of TFDA. TFDA actively established an analysis method with LC-MS/MS for simultaneous
analysis of 12 nitrosamine compounds such as NDMA in drugs in order to expand the application
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drugs. TFDA also lowered the quantitative limit to meet the regulatory standard.
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