An Evaluation of the Glass Vial Hydrolytic Resistance Method.
Alkalinity
Glass vials
Surface hydrolytic resistance
Journal
PDA journal of pharmaceutical science and technology
ISSN: 1948-2124
Titre abrégé: PDA J Pharm Sci Technol
Pays: United States
ID NLM: 9439538
Informations de publication
Date de publication:
Historique:
pubmed:
30
11
2018
medline:
11
2
2020
entrez:
29
11
2018
Statut:
ppublish
Résumé
The European Pharmacopoeia (Ph. Eur.) hydrolytic resistance method for glass vials is routinely used to screen pharmaceutical glass vial supply. In an effort to better understand and control the factors affecting method precision and robustness, several potential sources of variability in the Ph. Eur. alkalinity method have been studied for 3 cc glass vials. Method parameters including vial rinsing, vial covering, autoclave cycle execution, sample hold times, and titration procedure were evaluated in this study. The results of this study indicate the method parameters which require stringent control in order to achieve acceptable method precision and robustness.
Identifiants
pubmed: 30482802
pii: pdajpst.2018.008896
doi: 10.5731/pdajpst.2018.008896
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
212-219Informations de copyright
© PDA, Inc. 2019.