Mejía RLS, Peña PV, Arias PJ

Language: Spanish
References: 4
Page: 355-360
PDF size: 103.28 Kb.

ABSTRACT

The quantification technique of powdered tylosin was validated. To this end, the technique recommended by the United States Pharmacopeia, 30th version, 2007 was standardized to adapt it to and to comply with the international regulations. The sample was composed of 10 % tylosin phosphate and 90 % Carrier 40-60. The agar diffusion was used to test the micro-organism Micrococcus luteus ATCC 9341 and all results were microbiologically validated by the program "Validation Manager". The agar diffusion method met the prospective values, thus validating the technique.

REFERENCES

1. WHO. Expert Committee on Specifications for Pharmaceutical Preparations. Report 32. Geneva: WHO Press; 1992. Available from: http://libdoc.who.int/trs/WHO_TRS_823.pdf

2. WHO. Quality assurance of pharmaceuticals. Good manufacturing practices and inspection. Vol. 2. Geneva: WHO Press; 1999.

3. Adams Richard H. Farmacología y terapéutica veterinaria. 2ª ed. Zaragoza: Editorial Acribia; 2003. p. 937-43.

4. United States Pharmacopoeial Convention. USP XXX. United States Pharmacopoeia Convention. The official compendia of standards. 30 ed. Rockville: Mack Printing; 2007.