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...
Main Authors: | , |
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Format: | Article |
Language: | English |
Published: |
Elsevier
2020-09-01
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Series: | Arabian Journal of Chemistry |
Subjects: | |
Online Access: | http://www.sciencedirect.com/science/article/pii/S1878535220302719 |