An Isolated Method and Assignment for Critical Impurities in Semi-Synthetic Process of Arbekacin Sulfate.

Chemistry, Pharmaceutical / methods Chromatography, High Pressure Liquid / methods Dibekacin / analogs & derivatives Drug Contamination

Journal

Die Pharmazie
ISSN: 0031-7144
Titre abrégé: Pharmazie
Pays: Germany
ID NLM: 9800766

Informations de publication

Date de publication:
01 06 2019
Historique:
entrez: 30 5 2019
pubmed: 30 5 2019
medline: 31 3 2020
Statut: ppublish

Résumé

Four potential process related impurities were detected during the impurity profiling study of a semi-synthetic aminoglycoside antibiotic, arbekacin. The current preparation process from 3',4'-didehydro-dibekacin easily generates the specific impurities with similar structures to arbekacin that makes hard to separate and identify the residues. HPLC-ELSD and column chromatography loading weakly acidic cation exchange resin were used for the detection and isolation of these process impurities. Based on the synthesis and spectral data (ESI-MS/MS,

Identifiants

DOI: 10.1691/ph.2019.8242 PMID: 31138373
pubmed: 31138373
doi: 10.1691/ph.2019.8242
doi:

Substances chimiques

Dibekacin 45ZFO9E525
arbekacin G7V6SLI20L

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

352-356

Auteurs

Z H Chen (ZH)

H Zhou (H)

S Wang (S)

G Li (G)

J Zhang (J)

F Wang (F)

C Li (C)

R Z Qiao (RZ)

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Classifications MeSH

questionsmedicales.fr › Disciplines des sciences naturelles › Chimie › Chimie pharmaceutique › An Isolated Method and Assignment for Critical...
questionsmedicales.fr › Techniques d'investigation › Techniques de chimie analytique › Chromatographie › Chromatographie en phase liquide › Chromatographie en phase liquide à haute performance › An Isolated Method and Assignment for Critical...
questionsmedicales.fr › Glucides › Hétérosides › Aminosides › Kanamycine › Dibékacine › An Isolated Method and Assignment for Critical...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Contamination de médicament › An Isolated Method and Assignment for Critical...