Development and Validation of Biochemical Assay for Quality of Vaccine: Method Validation for Vaccine - Couverture souple

Kuskar, Sharmila; Pande, Vishal; Ahirrao, Vikas

9786204191874: Development and Validation of Biochemical Assay for Quality of Vaccine: Method Validation for Vaccine

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ISBN 10 : 620419187X ISBN 13 : 9786204191874

Editeur : LAP LAMBERT Academic Publishing, 2021

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Anthrone assay is a recent technique for polysaccharide estimation with several advantages like less interference. To employ this technique as routine quality control test in vaccine industry, validation of this method according to regulatory guidelines was necessary. In present study to validate this method and to generate reliable data, various experiments were designed for execution of different validation parameters.In the present work, the polysaccharide estimation using anthrone reagent has been found quite easier and reproducible. Range of linearity was observed to be 5-125 �g with correlation coefficient 0.999. Anthrone assay for determination of polysaccharide was found to be specific, precise, accurate, robust and stable. Hence it can be employed as routine quality control test for conjugate vaccine products.

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�diteur: LAP LAMBERT Academic Publishing
Date d'�dition: 2021
Langue: anglais
ISBN 10: 620419187X
ISBN 13: 9786204191874
Reliure: Broch�
Nombre de pages: 124
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Development and Validation of Biochemical Assay for Quality of Vaccine

Sharmila Kuskar|Vishal Pande|Vikas Ahirrao

Edit� par LAP LAMBERT Academic Publishing, 2021

ISBN 10 : 620419187X ISBN 13 : 9786204191874

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Etat : New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Autor/Autorin: Kuskar SharmilaMiss.Sharmila Deepak Kuskar is working as Assistant Professor, at RSM s NN Sattha College of Pharmacy Ahmednagar(Maharashtra).She has 2 years of teaching and 2.5 years as a hospital pharmacist. Miss Sharmila has an e. N� de r�f. du vendeur 505012035

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Development and Validation of Biochemical Assay for Quality of Vaccine

Sharmila Kuskar

Edit� par LAP LAMBERT Academic Publishing Aug 2021, 2021

ISBN 10 : 620419187X ISBN 13 : 9786204191874

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Taschenbuch. Etat : Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -Anthrone assay is a recent technique for polysaccharide estimation with several advantages like less interference. To employ this technique as routine quality control test in vaccine industry, validation of this method according to regulatory guidelines was necessary. In present study to validate this method and to generate reliable data, various experiments were designed for execution of different validation parameters.In the present work, the polysaccharide estimation using anthrone reagent has been found quite easier and reproducible. Range of linearity was observed to be 5-125 �g with correlation coefficient 0.999. Anthrone assay for determination of polysaccharide was found to be specific, precise, accurate, robust and stable. Hence it can be employed as routine quality control test for conjugate vaccine products. 124 pp. Englisch. N� de r�f. du vendeur 9786204191874

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Development and Validation of Biochemical Assay for Quality of Vaccine : Method Validation for Vaccine

Sharmila Kuskar

Edit� par LAP LAMBERT Academic Publishing, 2021

ISBN 10 : 620419187X ISBN 13 : 9786204191874

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Taschenbuch. Etat : Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - Anthrone assay is a recent technique for polysaccharide estimation with several advantages like less interference. To employ this technique as routine quality control test in vaccine industry, validation of this method according to regulatory guidelines was necessary. In present study to validate this method and to generate reliable data, various experiments were designed for execution of different validation parameters.In the present work, the polysaccharide estimation using anthrone reagent has been found quite easier and reproducible. Range of linearity was observed to be 5-125 �g with correlation coefficient 0.999. Anthrone assay for determination of polysaccharide was found to be specific, precise, accurate, robust and stable. Hence it can be employed as routine quality control test for conjugate vaccine products. N� de r�f. du vendeur 9786204191874

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Development and Validation of Biochemical Assay for Quality of Vaccine

Sharmila Kuskar

Edit� par LAP LAMBERT Academic Publishing Aug 2021, 2021

ISBN 10 : 620419187X ISBN 13 : 9786204191874

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Vendeur : buchversandmimpf2000, Emtmannsberg, BAYE, Allemagne

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Taschenbuch. Etat : Neu. Neuware -Anthrone assay is a recent technique for polysaccharide estimation with several advantages like less interference. To employ this technique as routine quality control test in vaccine industry, validation of this method according to regulatory guidelines was necessary. In present study to validate this method and to generate reliable data, various experiments were designed for execution of different validation parameters.In the present work, the polysaccharide estimation using anthrone reagent has been found quite easier and reproducible. Range of linearity was observed to be 5-125 �g with correlation coefficient 0.999. Anthrone assay for determination of polysaccharide was found to be specific, precise, accurate, robust and stable. Hence it can be employed as routine quality control test for conjugate vaccine products.Books on Demand GmbH, �berseering 33, 22297 Hamburg 124 pp. Englisch. N� de r�f. du vendeur 9786204191874

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