Qualitative and quantitative comparison of different commercially available 1-84 parathyroid hormone proteins to the WHO international standard 95/646 using orthogonal methods.

Parathyroid Hormone / analysis Reference Standards World Health Organization
CE-UV LC-MS LC-UV PTH Protein content Quality control

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:
20 Sep 2022
Historique:
received: 28 04 2022
revised: 01 07 2022
accepted: 12 07 2022
pubmed: 22 7 2022
medline: 17 8 2022
entrez: 21 7 2022
Statut: ppublish

Résumé

Relative quantitation methods rely on the use of reference substances to determine the content of samples. The aim of this study was to compare 1-84 parathyroid hormone (PTH) standards from different manufacturers to the WHO international standard 95/646. CE and LC with UV detection were investigated as quick and inexpensive quantitation methods, with an emphasis on selectivity between intact 1-84 PTH and its oxidized forms. Both methods were fully validated according to ICH Q2R1. Moreover, method performance was also evaluated according to guidelines defining the maximum allowable measurement uncertainty (MU) of a biological parameter from its intraindividual variation (CV

Identifiants

DOI: 10.1016/j.jpba.2022.114942 PMID: 35863167
pubmed: 35863167
pii: S0731-7085(22)00363-6
doi: 10.1016/j.jpba.2022.114942
pii:
doi:

Substances chimiques

Parathyroid Hormone 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

114942

Informations de copyright

Copyright © 2022 Elsevier B.V. All rights reserved.

Auteurs

Laurent Nyssen (L)

Department of Clinical Chemistry, Center for Interdisciplinary Research on Medicines (CIRM), University of Liège, CHU de Liège, Liège, Belgium; Laboratory for the Analysis of Medicines (LAM), Center for Interdisciplinary Research on Medicines (CIRM), University of Liège, Liège, Belgium.

Marianne Fillet (M)

Laboratory for the Analysis of Medicines (LAM), Center for Interdisciplinary Research on Medicines (CIRM), University of Liège, Liège, Belgium.

Etienne Cavalier (E)

Department of Clinical Chemistry, Center for Interdisciplinary Research on Medicines (CIRM), University of Liège, CHU de Liège, Liège, Belgium.

Anne-Catherine Servais (AC)

Laboratory for the Analysis of Medicines (LAM), Center for Interdisciplinary Research on Medicines (CIRM), University of Liège, Liège, Belgium. Electronic address: acservais@uliege.be.

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Classifications MeSH

questionsmedicales.fr › Acides aminés, peptides et protéines › Peptides › Hormones peptidiques › Hormone parathyroïdienne › Qualitative and quantitative comparison of...
questionsmedicales.fr › Techniques d'investigation › Poids et mesures › Normes de référence › Qualitative and quantitative comparison of...
questionsmedicales.fr › Organisations et économie des soins de santé › Organismes › Agences internationales › Nations Unies › Organisation mondiale de la santé › Qualitative and quantitative comparison of...