Arias PJ, Ortiz GDS, González AA

Language: Spanish
References: 3
Page: 178-184
PDF size: 101.15 Kb.

ABSTRACT

Objective: to validate and to implement a methodology for microbiological analysis of a liquid product preserved with parabens produced by a pharmaceutical company, based on the United States Pharmacopeia analytical methods, XXXIV version, 2011.
Methods: the quantitative tests were carrying out for Staphylococcus aureus and Candida albicans, and qualitative tests for Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa.
Results: the results were consistent with those established by the USP. The described methodology was considered reproducible and robust because of its capacity of being unaffected by variations when implementing the technique, thus generating reliable and accurate results.
Conclusions: all validation parameters met the USP specification, showing compliance with all the evaluated parameters.

REFERENCES

1. The United States Pharmacopeia. USP 34. The National Formulary, NF 29. The United States Phamacopeia. The official compendia of standards. Rockville: Mack Printing; 2011.

2. WHO. Quality assurance of pharmaceuticals. Vol 2. Good manufacturing practices and inspection. Geneva: Word Health Organization; 2010. p. 27-39.

3. Arthur K. Handbook of Pharmaceutical Excipients. London: American Pharmaceutical Association and Pharmaceutical Press; 3th ed. 2000. p. 340-2, 450-2, 510.