QbD-mediated RP-UPLC method development invoking an FMEA-based risk assessment to estimate nintedanib degradation products and their pathways

QbD is considered an important, fundamental, and integral part of dosage form development. Despite its significance in drug formulations, the knowledge, reference, and guidance for using QbD in analytical science have not been thoroughly documented in the literature. The present study is aimed at br...

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Bibliographic Details
Main Authors: Balaji Jayagopal, Shivashankar Murugesh
Format: Article
Language:English
Published: Elsevier 2020-09-01
Series:Arabian Journal of Chemistry
Subjects:
QbD
MS
Online Access:http://www.sciencedirect.com/science/article/pii/S1878535220302719