Organon Korea "No NDPA detected in Singulair¡±
By | translator Alice Kang
22.04.06 14:05:08
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Safety of montelukast ingredient verified
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 b
(same@dailypharm.com)
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