Identification of unknown impurities J, RRT 2.2, 2.4, 2.6 and 3.4 in tetralysal® capsules.

Autor: Billié S; Galderma SA, Av. d'Ouchy 4, Lausanne 1006, Switzerland., Reversé K; Nuvisan France SARL - CS 10287, Sophia-Antipolis 06905, France., Arlabosse JM; Nuvisan France SARL - CS 10287, Sophia-Antipolis 06905, France., Bertin D; Galderma SA, Av. d'Ouchy 4, Lausanne 1006, Switzerland., Boulier A; Laboratoires Galderma SAS, ZI Montdésir, Alby-sur-Chéran 74540, France., Cachot T; Nuvisan France SARL - CS 10287, Sophia-Antipolis 06905, France., Chambon S; Nuvisan France SARL - CS 10287, Sophia-Antipolis 06905, France., Charras K; Laboratoires Galderma SAS, ZI Montdésir, Alby-sur-Chéran 74540, France. Electronic address: karine.charras@galderma.com., Cren C; Galderma SA, Av. d'Ouchy 4, Lausanne 1006, Switzerland., Furnes B; Galderma SA, Av. d'Ouchy 4, Lausanne 1006, Switzerland., Gerfaud T; Nuvisan France SARL - CS 10287, Sophia-Antipolis 06905, France., Joly-Battaglini M; Galderma SA, Av. d'Ouchy 4, Lausanne 1006, Switzerland., Longoni D; Olon SpA, Strada Rivoltana, km 6/7, Rodano, Milan 20053, Italy., Mouis G; Nuvisan France SARL - CS 10287, Sophia-Antipolis 06905, France., Pierre R; Nuvisan France SARL - CS 10287, Sophia-Antipolis 06905, France., Raynard H; Galderma SA, Av. d'Ouchy 4, Lausanne 1006, Switzerland., Texier T; Nuvisan France SARL - CS 10287, Sophia-Antipolis 06905, France., Trognon C; Galderma SA, Av. d'Ouchy 4, Lausanne 1006, Switzerland., Zanelli U; Galderma SA, Av. d'Ouchy 4, Lausanne 1006, Switzerland., Boiteau JG; Nuvisan France SARL - CS 10287, Sophia-Antipolis 06905, France. Electronic address: Jean-Guy.Boiteau@nuvisan.com., Harris CS; Galderma SA, Av. d'Ouchy 4, Lausanne 1006, Switzerland. Electronic address: craigstevenharris@gmail.com.
Jazyk: angličtina
Zdroj: European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences [Eur J Pharm Sci] 2023 Sep 01; Vol. 188, pp. 106519. Date of Electronic Publication: 2023 Jul 19.
DOI: 10.1016/j.ejps.2023.106519
Abstrakt: 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.
(Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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