Isolation and identification of ester impurities in RG7128, an HCV polymerase inhibitor.
J Pharm Biomed Anal
; 53(3): 710-6, 2010 Nov 02.
Article
en En
| MEDLINE
| ID: mdl-20439144
ABSTRACT
RG7128 is a di-ester prodrug of a cytidine analog for the treatment of hepatitis C virus (HCV) infection. The structures of nine low level impurities (0.05-0.10%) in RG7128 drug substance were elucidated. The majority of the impurities were formed during the synthesis of the prodrug from the parent drug. Structural elucidations of the impurities were achieved either by enrichment of the impurities using preparative chromatography followed by spectroscopic techniques or by confirmation with a reference sample. Heart-cut and recycle chromatographic techniques were applied to purify closely eluting isomers of RG7128.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Antivirales
/
ARN Polimerasa Dependiente del ARN
/
Contaminación de Medicamentos
/
Hepatitis C
/
Desoxicitidina
Tipo de estudio:
Diagnostic_studies
Idioma:
En
Revista:
J Pharm Biomed Anal
Año:
2010
Tipo del documento:
Article
País de afiliación:
Estados Unidos