Introduction to Analytical Method Development and Validation - Couverture souple

Punagoti, Raja Abhilash; Jupally, Venkateshwar Rao

 
9783639711257: Introduction to Analytical Method Development and Validation
Couverture souple
ISBN 10 : 3639711254 ISBN 13 : 9783639711257
Editeur : Scholars' Press, 2014

Synopsis

Method development is the process of proving that an analytical method is acceptable for use in our laboratory to measure the concentration of an API in a specific compounded dosage form. Full method development procedures are complex, extended, and expensive endeavors. These studies usually are required when data from the analysis is going to be submitted to regulatory authorities for certification of a new or amended drug application. The analytical method is tested extensively for specificity, linearity, accuracy, precision, range, detection limit, quantitation limit, and robustness. For established pharmaceutical preparations, which are not new drug species, the analytical method process can be much simpler. Modern analytical instrumentations, like HPLC,UPLC,HPTLC and UV, allow simplified procedures to be employed to verify that an analysis procedure accurately and consistently will deliver a reliable measurement of an active ingredient in a compounded preparation and biological fluids. This book will provide basics for method development and validation for aspirants in analytical chemistry

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Présentation de l'éditeur

Method development is the process of proving that an analytical method is acceptable for use in our laboratory to measure the concentration of an API in a specific compounded dosage form. Full method development procedures are complex, extended, and expensive endeavors. These studies usually are required when data from the analysis is going to be submitted to regulatory authorities for certification of a new or amended drug application. The analytical method is tested extensively for specificity, linearity, accuracy, precision, range, detection limit, quantitation limit, and robustness. For established pharmaceutical preparations, which are not new drug species, the analytical method process can be much simpler. Modern analytical instrumentations, like HPLC,UPLC,HPTLC and UV, allow simplified procedures to be employed to verify that an analysis procedure accurately and consistently will deliver a reliable measurement of an active ingredient in a compounded preparation and biological fluids. This book will provide basics for method development and validation for aspirants in analytical chemistry

Biographie de l'auteur

Author is having 8 years of rich experience in teaching for B.Pharmacy and M.pharmacy and published 22 research publications in various national and international renowned journals. Presently working as HOD for the department of Pharmaceutical Analysis and Quality Assurance in SVS Group of Institutions, School of Pharmacy.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
Scholars' Press
Date d'édition
2014
Langue
anglais
ISBN 10 
3639711254
ISBN 13 
9783639711257
Reliure
Broché
Nombre de pages
84
Coordonnées du fabricant
non disponible
Personne responsable
non disponible