Abstract

LAGARTO PARRA, Alicia; GARCIA PENA, Caridad; GABILONDO RAMIREZ, Tatiana  and  TRIANA MANSO, Osmaida. Validation of the biological potency test for human chorionic gonadotropin. Rev Cubana Farm [online]. 2012, vol.46, n.2, pp.183-190. ISSN 0034-7515.

Introduction: a number of biological tests for quality control used in the Center for Drug Research and Development should be validated. Biological potency test of human chorionic gonadotropin is one of them. Objective: to evaluate the performance of the human chorionic gonadotropin biological potency test. Methods: the accuracy, precision and specificity were evaluated as validation parameters according to the 41-2007 Regulation of the Center for the State Control of Drug Quality (CEDMED) for analysis method validation. Results: in the accuracy test, no significant differences were observed between the uterus weight values from tested sample and the reference material at the 3 tested doses. Variation coefficients were less than 50 % in the repeatability test. There were no significant differences between the precision values of two different analysts at different times. The specificity test showed that excipients or auxiliary substances in the formulation did not interfere with the results of the biologic potency test of the final product. Conclusions: the validated biological method showed good accuracy, precision and specificity in the range of studied concentrations, all of which proved its quality, so it has added value.

Keywords : validation; biologic method; gonadotropin.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )