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Revista Cubana de Farmacia
versão impressa ISSN 0034-7515
Resumo
MEJIA RANGEL, Luz Stella; PENA PAEZ, Viviana e ARIAS PALACIOS, Janeth. Validation of technique for the quantification of tylosin in a solid product. Rev Cubana Farm [online]. 2011, vol.45, n.3, pp. 355-360. ISSN 0034-7515.
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.
Palavras-chave : tylosin; validation; Micrococcus luteus; Agar diffusion.