- Funahashi, Yasuhiro; Tsuruoka, Akihiko; Matsukura, Masayuki; Haneda, Toru; Fukuda, Yoshio; Kamata, Junichi; Takahashi, Keiko; Matsushima, Tomohiro; Miyazaki, Kazuki; Nomoto, Kenichi; et al, Nitrogenous Aromatic Ring Compounds As Anti Cancer Agents, EP1415987B1, February 28, 2007
- Mano, Yuji; Kusano, Kazutomi, A validated LC-MS/MS method of total and unbound lenvatinib quantification in human serum for protein binding studies by equilibrium dialysis, Journal of Pharmaceutical and Biomedical Analysis, Volume: 114, Pages: 82-87, 2015
Frequently Asked Questions
Impurity profiling and risk assessment are performed during the drug development to identify and evaluate Lenvatinib impurities. Strategies help control and minimize their presence.
Impurities in Lenvatinib can form during the manufacturing process, storage conditions, or due to interactions with other components. Factors such as temperature, pH, and exposure to light can contribute to impurity formation.
Regulatory authorities, such as the United States Pharmacopeia (USP) or the International Council for Harmonization (ICH), provide guidelines on acceptable limits for impurities in Lenvatinib to ensure its safety and quality.
Impurities in Lenvatinib have the potential to impact its efficacy or safety. Some may have toxic effects or alter the drug's therapeutic properties, making it crucial to control them within acceptable limits.
The recommendation is to store Lenvatinib impurities at a controlled room temperature, within 2-8 °C.
Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.