Evaluation and establishment of new quality specification to immunoglobulin and albumin

The limits of quality specification for the parameter alcohol content, using 50 industrial batches of immunoglobulin and albumin, were calculated employing Bowker's method to get the upper specification limits for three different conditions. All the measurements of the alcohol content as impuri...

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Autores principales: Carrillo Cabrera, Dianelys, González Farah, Ambar, Rodríguez Bernal, Josefina, Suárez Pérez, Yania, Fernández Cervera, Mirna, Veliz Rivera, Jacqueline
Formato: Articulo
Lenguaje:Inglés
Publicado: 2011
Materias:
Farmacia
Globulinas
albumin; alcohol content; bowker's method; immunoglobulin; quality specifications
Proteínas Sanguíneas
Control de Calidad
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/8259
http://www.latamjpharm.org/resumenes/30/6/LAJOP_30_6_1_1.pdf
Aporte de:
SEDICI (UNLP) de Universidad Nacional de La Plata
id I19-R120-10915-8259
record_format dspace
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Inglés
topic Farmacia
Globulinas
albumin; alcohol content; bowker's method; immunoglobulin; quality specifications
Proteínas Sanguíneas
Control de Calidad
spellingShingle Farmacia
Globulinas
albumin; alcohol content; bowker's method; immunoglobulin; quality specifications
Proteínas Sanguíneas
Control de Calidad
Carrillo Cabrera, Dianelys
González Farah, Ambar
Rodríguez Bernal, Josefina
Suárez Pérez, Yania
Fernández Cervera, Mirna
Veliz Rivera, Jacqueline
Evaluation and establishment of new quality specification to immunoglobulin and albumin
topic_facet Farmacia
Globulinas
albumin; alcohol content; bowker's method; immunoglobulin; quality specifications
Proteínas Sanguíneas
Control de Calidad
description The limits of quality specification for the parameter alcohol content, using 50 industrial batches of immunoglobulin and albumin, were calculated employing Bowker's method to get the upper specification limits for three different conditions. All the measurements of the alcohol content as impurity were performed by an enzymatic method. In addition, the behaviour of the parameter alcohol content was evaluated after the quality specification limits were estimated. The results of the follow-up phase of the 30 industrial batches were processed statistically giving best performance for the immunoglobulin. Using the control charts as tool, showed that both process were under a state of statistical control, and tend to be a capable process for immunoglobulin when Q = 99 %
format Articulo
Articulo
author Carrillo Cabrera, Dianelys
González Farah, Ambar
Rodríguez Bernal, Josefina
Suárez Pérez, Yania
Fernández Cervera, Mirna
Veliz Rivera, Jacqueline
author_facet Carrillo Cabrera, Dianelys
González Farah, Ambar
Rodríguez Bernal, Josefina
Suárez Pérez, Yania
Fernández Cervera, Mirna
Veliz Rivera, Jacqueline
author_sort Carrillo Cabrera, Dianelys
title Evaluation and establishment of new quality specification to immunoglobulin and albumin
title_short Evaluation and establishment of new quality specification to immunoglobulin and albumin
title_full Evaluation and establishment of new quality specification to immunoglobulin and albumin
title_fullStr Evaluation and establishment of new quality specification to immunoglobulin and albumin
title_full_unstemmed Evaluation and establishment of new quality specification to immunoglobulin and albumin
title_sort evaluation and establishment of new quality specification to immunoglobulin and albumin
publishDate 2011
url http://sedici.unlp.edu.ar/handle/10915/8259
http://www.latamjpharm.org/resumenes/30/6/LAJOP_30_6_1_1.pdf
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AT suarezperezyania evaluationandestablishmentofnewqualityspecificationtoimmunoglobulinandalbumin
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