Advancing Quality and Environmental Responsibility: A Stability-Indicating LC Method Development for Lenvatinib Through QbD and Green Chemistry
Author:
Publisher
Springer Science and Business Media LLC
Subject
Organic Chemistry,Clinical Biochemistry,Biochemistry,Analytical Chemistry
Link
https://link.springer.com/content/pdf/10.1007/s10337-023-04271-2.pdf
Reference46 articles.
1. Zigart N, Casa Z (2020) Development of a stability-indicating analytical method for determination of venetoclax using AQbD principles. ACS Omega 5:17726
2. International council for Harmonization (2003) ICH Topic Q 1 A (R2) Stability Testing of new Drug Substances and Products Step 5 Note for guidance on stability testing: stability testing of new drug substances and products
3. Sehrawat R, Maithani M, Singh R (2010) Regulatory aspects in development of stability-indicating methods: a review. Chromatographia 72:1–6. https://doi.org/10.1365/S10337-010-1612-Z
4. Kalal DJ, Redasani VK (2022) Stability-indicating RP-HPLC method development and validation for estimation of Mupirocin calcium in bulk and in pharmaceutical formulation. Futur J Pharm Sci. https://doi.org/10.1186/S43094-022-00412-W
5. Bhavna BS, Ojha A (2022) International Council for Harmonisation (ICH) guidelines. Regulatory Affairs in the Pharmaceutical Industry. Elsevier, Amsterdam, pp 47–74
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