Development of chromatographic methods for the determination of genotoxic impurities in cloperastine fendizoate.
García A1, Rupérez FJ, Ceppa F, Pellati F, Barbas C.
Journal of pharmaceutical and biomedical analysis.J Pharm Biomed Anal.2012 Mar 5;61:230-6. doi: 10.1016/j.jpba.2011.12.014. Epub 2011 Dec 19.
The classification of an impurity of a drug substance as genotoxic means that the "threshold of toxicological concern" (TTC) value of 1.5 μg/day intake, considered to be associated with an acceptable risk, should be the admissible limit in the raw material and that leads to new analytical challenge
Cloperastine Fendizoate is a medicine available in a number of countries worldwide. A list of US medications equivalent to Cloperastine Fendizoate is available on the Drugs.com website. ... Drugs.com provides accurate and ...