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Dedicated experts in extractables and leachables and genotoxic impurities (GTIs) deploy organic trace analysis by liquid chromatography-mass spectrometry (LC-MS), as well as gas chromatography-mass spectrometry (GC-MS) equipment. However, messenger RNA (mRNA) based vaccines present particular analytical challenges.
The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in vivo mammalian systems. “We Animals were administered molnupiravir for longer and at higher doses (mg/Kg) than those employed in human studies.
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