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

Kuskar, Sharmila; Pande, Vishal; Ahirrao, Vikas

Softcover

ISBN 10: 620419187X ISBN 13: 9786204191874

Verlag: LAP LAMBERT Academic Publishing, 2021

Inhaltsangabe

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 µg 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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Über die Autorin bzw. den Autor

Miss.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 excellent track record in academic institutions of high repute and actively engaged in teaching, administration and research.

Details zur Ausgabe

• Verlag: LAP LAMBERT Academic Publishing
• Erscheinungsdatum: 2021
• Sprache: Englisch
• ISBN 10: 620419187X
• ISBN 13: 9786204191874
• Einband: Taschenbuch
• Anzahl der Seiten: 124
• Kontakt zum Hersteller: Nicht verfügbar
• Verantwortliche Person: SIA OmniScriptum Publishing; customerservice@vdm-vsg.de; ; Brivibas gatve 197; Riga; 1039; Lettland