Completion of the impurity profile of lymecycline: Formal identification of impurities E and F
Journal of Pharmaceutical and Biomedical Analysis(2022)
摘要
Lymecycline is the drug substance (DS) used in the Galderma drug product Tetralysal® capsules with 7 impurities currently described in the pharmacopeia labelled as A-G. In the current monograph, the structural identity of all impurities except E and F have been formally identified. In this manuscript, through both formal synthesis and preparative chromatography, we are the first group to confirm the structural identity, response factor of Impurity F and conditions which exacerbate the formation of both impurities.
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关键词
Lymecycline,Thermal degradation,4-desmethylaminotetracycline,C5a-5 dehydro-tetracycline,Polonovski reaction
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