Completion of the impurity profile of lymecycline: Formal identification of impurities E and F.
4-desmethylaminotetracycline
C5a-5 dehydro-tetracycline
Lymecycline
Polonovski reaction
Thermal degradation
Journal
Journal of pharmaceutical and biomedical analysis
ISSN: 1873-264X
Titre abrégé: J Pharm Biomed Anal
Pays: England
ID NLM: 8309336
Informations de publication
Date de publication:
25 Oct 2022
25 Oct 2022
Historique:
received:
13
05
2022
revised:
08
08
2022
accepted:
08
08
2022
pubmed:
26
8
2022
medline:
21
9
2022
entrez:
25
8
2022
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 36007309
pii: S0731-7085(22)00414-9
doi: 10.1016/j.jpba.2022.114993
pii:
doi:
Substances chimiques
Capsules
0
Lymecycline
7D6EM3S13P
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
114993Informations de copyright
Copyright © 2022 Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.