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  • Organon Korea "No NDPA detected in Singulair¡±
  • by | translator Alice Kang | Apr 7, 2022 06:10am
Safety of montelukast ingredient verified
Organon Korea announced on the 6th that no impurities were detected in ¡®montelukast,¡¯ the active ingredient of the allergic rhinitis and asthma treatment ¡®Singulair.¡¯

Organon Korea had conducted an impurity investigation for N- nitrosodipropylamine (NDPA) in January after the Ministry of Food and Drug Safety ordered companies to investigate the possibility of impurities. The company had brought in the active pharmaceutical ingredient used for the manufacture of Singulair for investigations in Korea.

The company used a liquid chromatography-mass spectrometry device (LC-MS/MS) that could detect minimal amounts of the impurity. The results of the investigation and assessment data will be submitted to the MFDS
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