Forced degradation studies to identify organic impurities in pharmaceuticals: a Brazilian perspective
Rev. ciênc. farm. básica apl
;
42: 1-13, 20210101.
Article
Dans Anglais
|
LILACS-Express
| LILACS
| ID: biblio-1280855
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.
Texte intégral:
Disponible
Indice:
LILAS (Amériques)
Type d'étude:
Étude pronostique
Pays comme sujet:
Amérique du Sud
/
Brésil
langue:
Anglais
Texte intégral:
Rev. ciênc. farm. básica apl
Thème du journal:
Pharmacologie
Année:
2021
Type:
Article
Pays d'affiliation:
Brésil
Institution/Pays d'affiliation:
Departamento de Análises Clínicas e Toxicológicas/BR
/
Núcleo de Ensaios Físicos e Químicos em Medicamentos/BR
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