Page 50 - 2021 Taiwan Food and Drug Administration Annual Report

liquid chromatography - tandem MS $FKLHYHPHQWV DQG %HQH¿WV
(LC-MS/MS) and gas chromatography -
tandem mass spectrometry (GC-MS/MS).
The multi-residue analysis platform built
with these two technologies expands the
scope of application to the detection of
nitrosamine impurities in high-risk drugs.
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the analysis of nitrosamine compounds are
improved through sample pretreatment and
chromatographic condition adjustment tests.
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nitrosamine impurities were included in the
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expanded on a rolling basis.
II. Applied research in drug sta-
bility investigation, and receive
immediate feedback on test
results
TFDA used the established and
optimized multi-residue analysis and testing
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and explores the trends of generation of
nitrosamine impurities in the gastric drug
Ranitidine and the hypoglycemic drug
Metformin and their correlation with time
and temperature. The results are immediately
returned to the administrative management
agencies and the industry operators to be
used as a reference basis for impurity control
measures.
48
Established a platform for multi-residue
analysis and detection of nitrosamines
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development of 44 screening and analysis
methods for 11 kinds of nitrosamine
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academic results were published in the “17th
Taiwan Mass Spectrometry Annual Academic
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The recommended test methods for the
application of LC-MS/MS and GC-MS/MS
on multi-residue analysis for nitrosamine
compounds were published on TFDA’s
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for relevant agencies to gain an in-depth
understanding and use as a reference.
TFDA continued to build testing
technologies and databases for nitrosamine
impurities in pharmaceuticals to strengthen
the testing capacity of national laboratories
that may need to take response measures for
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data from the Chinese Pharmacopoeia to
revise relevant general rules. TFDA apply
analysis results for immediate feedback
to administrative units and industries as a
reference for impurity control measures.