In situ degradation: a new concept for system suitability tests in monographs of the European Pharmacopoeia.
J Pharm Biomed Anal
; 18(1-2): 1-14, 1998 Oct.
Article
en En
| MEDLINE
| ID: mdl-9863938
ABSTRACT
Monographs of the European Pharmacopoeia describe in the LC-test for related substances usually a system suitability test in order to ensure the adequate separation of impurities. Since the reference substances required are often not available a recent approach to avoid this problem is the generation of the required impurity by 'in situ degradation' of the active principle. This paper describes some typical applications of this technique as well as recent examples, such as the controlled degradation of cefalotin sodium, imipenem and spiramycin.
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Banco de datos:
MEDLINE
Asunto principal:
Farmacopeas como Asunto
/
Técnicas de Química Analítica
/
Contaminación de Medicamentos
/
Cromatografía
Idioma:
En
Año:
1998
Tipo del documento:
Article