In contrast to other impurities the control of extractable and leachables is not well defined yet. Currently guidance is provided e.g. by USP and PQRI, but there is room for interpretation. New guidance (ICHQ3E) is being developed. In general, comprehensive screening is applied, using gas- and liquid chromatography techniques hyphenated with mass spectrometry, to aim for complete coverage on E&L. Although considered to be the state-of-the -art approach, in practice this approach is not as straightforward as it may seem. Many assumptions are made and for effective approach an E&L database is deemed necessary. Moreover, the strategy is completely opposite compared to the strategy applied for potential mutagenic impurities which is highly relying on a theoretical assessment (Risk based approach). The presentation will focus on the analytical technique selection, challenges of coverage of E&L in the current strategy and finally a perspective on E&L analysis.

Hora

16:00 - 17:00 hs GMT+1

Organizador

BioPharma Asia Magazine
Compartir
Enviar a un amigo
Mi email *
Email destinatario *
Comentario *
Repite estos números *
Control de seguridad
Junio / 2021 2168 webinars
Lunes
Martes
Miércoles
Jueves
Viernes
Sábado
Domingo
Lun 31 de Junio de 2021
Mar 01 de Junio de 2021
Mié 02 de Junio de 2021
Jue 03 de Junio de 2021
Vie 04 de Junio de 2021
Sáb 05 de Junio de 2021
Dom 06 de Junio de 2021
Lun 07 de Junio de 2021
Mar 08 de Junio de 2021
Mié 09 de Junio de 2021