Identification of unknown impurities J, RRT 2.2, 2.4, 2.6 and 3.4 in tetralysal® capsules.
12-aminotetracycline
Allotetracycline
Retro-Claisen
Tetralysal®
Journal
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
ISSN: 1879-0720
Titre abrégé: Eur J Pharm Sci
Pays: Netherlands
ID NLM: 9317982
Informations de publication
Date de publication:
01 Sep 2023
01 Sep 2023
Historique:
received:
19
05
2023
revised:
16
06
2023
accepted:
05
07
2023
medline:
23
10
2023
pubmed:
22
7
2023
entrez:
21
7
2023
Statut:
ppublish
Résumé
Tetralysal® is a Galderma oral drug product (DP) marketed for the treatment of acne. Tetralysal® is sold in capsules containing either 150 mg or 300 mg of the drug substance. In the British Pharmacopoeia monograph for Lymecycline Capsules, the impurities already specified in the drug substance (A-G), visible in the European Pharmacopoeia 〈1654〉, are also specified together with an unidentified impurity at RRT 1.6 (Impurity J). Based on both monographs Galderma has focused on characterizing most of specified and unspecified impurities to better understand the stability and degradation processes of the formulation. In this manuscript, through both formal synthesis, preparative LCMS and formal degradation studies, we are the first group to confirm the structural identities of 5 unidentified impurities (Impurity J (RRT 1.6), RRT 2.2, 2.4, 2.6 and 3.4), conditions which exacerbate the formation of all 5 impurities and response factors for RRT 2.2, 2.6 and 3.4.
Identifiants
pubmed: 37478583
pii: S0928-0987(23)00149-5
doi: 10.1016/j.ejps.2023.106519
pii:
doi:
Substances chimiques
Lymecycline
7D6EM3S13P
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
106519Informations de copyright
Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.