Forced degradation studies to identify organic impurities in pharmaceuticals: a Brazilian perspective
Rev. ciênc. farm. básica apl
; Rev. ciênc. farm. básica apl;42: 1-13, 20210101.
Article
em En
|
LILACS-Express
| LILACS
| ID: biblio-1280855
Biblioteca responsável:
BR1851.9
ABSTRACT
Objective:
The aim of this study was to highlight and sediment the necessary steps to be followed while conducting forced degradation studies to identify degradation products and to describe the Brazilian and international regulations associated with degradation studies of drugs and drug products.Methods:
This review was conducted based on the Brazilian guidance tools as RDC 53/2015, Guide 4 and Question and Answer resource; references used as international guides; and articles in the field of degradation product analyses.Results:
Characterization of the impurity profile for a substance, and development of indicative stability methods are essential criteria for compliance with current legislation, and address a legitimate health concern. As this matter falls under the purview of recently published regulation, many doubts remain regarding methods of conducting studies of forced degradation, and development of methods indicative of stability. Analytical conditions predict degradation after exposing them to thermal, humid, acidic, basic, oxidation, photolytic, and metal ion conditions.Conclusions:
Although RDC 53/2015 outlines the parameters of degradation, the analytical conditions are not specified, as well as in other international standards. A well-designed forced degradation study is key to obtaining a good stability indicating method with peak purity and mass balance.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
LILACS
Tipo de estudo:
Prognostic_studies
País/Região como assunto:
America do sul
/
Brasil
Idioma:
En
Revista:
Rev. ciênc. farm. básica apl
Assunto da revista:
FARMACOLOGIA
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Brasil
País de publicação:
Brasil