Lercanidipine - NDSRI's
References
FAQ's
References
- Nardi, Dante; Leonardi, Amedeo; Graziani, Gabriele; Bianchi, Giorgio, Asymmetrical Diesters Of 1,4-Dihydro-2,6-Dimethyl-Pyridine-3,5-Dicarboxylic Acid, Recordati S. A. Chemical and Pharmaceutical Co., Switzerland, EP153016B1, May 16, 1990
- Alvarez-Lueje, A.; Pujol, S.; Squella, J. A.; Nunez-Vergara, L. J., A selective HPLC method for determination of lercanidipine in tablets, Journal of Pharmaceutical and Biomedical Analysis, Volume: 31, Issue: 1,Pages: 1-9, 2003
Frequently Asked Questions
What steps are taken to identify and characterize Lercanidipine impurities?
Extensive analytical testing is conducted to identify and characterize impurities in Lercanidipine. Techniques such as liquid chromatography-mass spectrometry (LC-MS) and nuclear magnetic resonance (NMR) spectroscopy help in impurity profiling.
Are Lercanidipine impurities monitored throughout its shelf life?
Lercanidipine impurities are monitored throughout their shelf life to ensure their levels remain within acceptable limits. Stability studies help assess their degradation and formation over time.
Can Lercanidipine impurities be removed or reduced through purification processes?
Yes, purification processes during the manufacturing of Lercanidipine can help remove or reduce impurities. Techniques like recrystallization, filtration, or chromatography help improve the purity of the drug substance.
How should Lercanidipine impurities be stored in terms of temperature?
The recommendation is to store Lercanidipine impurities at a controlled room temperature, within 2-8 °C.
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