Lagarto PA, García PC, Gabilondo RT, Triana MO

Language: Spanish
References: 5
Page: 183-190
PDF size: 57.87 Kb.

ABSTRACT

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.

REFERENCES

1. USP 32. Ensayo de valoración de gonadotrofina coriónica humana. Monografía Chorionic Gonadotropin. Rockville: United Pharmacopoeial Convention, Inc.; 2009. [CD-rom].

2. CECMED. Validación de Métodos Analíticos. Regulación Nº 41-2007. La Habana: MINSAP; 2007.

3. FDA. Analytical procedures and methods validation chemistry, manufacturing, and controls documentation. Guidance for Industry. Center for Biologics Evaluation and Research.Silver Spring, MD: FDA; 2002.

4. International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use. Validation of analytical procedures: Text and Methodology, Q2(R1). Geneva: ICH; 2005.

5. USP 32. General Chapter 1225. Validation of compendial methods. United States Pharmacopeia XXXII. Rockville: United Pharmacopoeial Convention, Inc.; 2009. [CD-rom].