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Level 1: identification by retention times (compared against in-house authentic standards), accurate mass (with an accepted deviation of 3 ppm), and MS/MS spectra, Level 2a: identification by retention times (compared against in-house authentic standards), accurate mass (with an accepted deviation of 3ppm)

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Before a new drug can be marketed in the United States, it must undergo extensive preclinical testing in the laboratory and in animal studies