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Cleft palate without cleft lip occurs in 1 in 1574 live births [1]

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racemization during synthesis or storage reduces potency substantially and is not detectable by standard reverse-phase HPLC (requires chiral HPLC)

Roberts DW, Lee WM, Hinson JA, Bai S, Swearingen CJ, Stravitz RT, Reuben A, Letzig L, Simpson PM, Rule J, Fontana RJ, Ganger D, Reddy KR, Liou I, Fix O, James LP