1.
J Pharm Biomed Anal
; 220: 114993, 2022 Oct 25.
Artigo
em Inglês
| MEDLINE
| ID: mdl-36007309
RESUMO
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.