Evaluation of stability using one versus three tubes for each quality control concentration in matrix-based bioanalysis.
Bioanalysis
; 11(20): 1823-1834, 2019 Oct.
Article
em En
| MEDLINE
| ID: mdl-31657231
ABSTRACT
Aim:
Contract research organizations and pharmaceutical firms have performed stability testing using one of twomethods:
storing in the freezer a single tube of matrix for each quality control concentration (Method 1), followed by aliquoting and analysis; and storing three tubes for each quality control concentration, followed by analysis (Method 2). This research project was conducted to determine if there were detectable differences between Method 1 and Method 2.Methodology:
Five model drugs were selected teriflunomide (stable compound) and acetyl salicylic acid, simvastatin, tenofovir alafenamide and valganciclovir (stability concerns). Samples were stored at -80°C for 1, 3 and 12 months and then analyzed. Samples were also placed at different locations within the freezer.Results:
For the drugs tested, the results suggest that there is no significant difference in the outcome of stability testing, regardless whether Method 1 or Method 2 was followed.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Técnicas de Química Analítica
Tipo de estudo:
Evaluation_studies
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article