Validation of microbiological assay for determination of cefuroxime in injectable preparations

The validation of a microbiological assay, applying agar diffusion method for determination of the active of cefuroxime in power for injection, is described. Using a strain of Micrococcus luteus ATCC 9341 as the test organism, cefuroxime was measured in concentrations ranging from 30.0 to 120.0 μg/mL. The method validation showed that it is linear (r = 0.9999), precise (relative standard deviation = 0.37 %) and accurate (it measured the added quantities). Microbiological assay is satisfactory for quantitation of cefuroxime in powder for injection and the validity of the proposed bioassay, which is a simple and a useful alternative methodology for cefuroxime determination in routine quality control.Colegio de Farmacéuticos de la Provincia de Buenos Aire

Microbiological control of packaging materials for medicines and cosmetics

As exigências dos consumidores e agências reguladoras, associadas à necessidade de embalagens mais eficientes, seguras, com boa qualidade microbiana conduziram à obtenção de embalagens que garantam a integridade do produto e a saúde do usuário. Entretanto, a embalagem pode ser fonte de contaminação quando não obedece ao critério de qualidade microbiana. O objetivo desta pesquisa foi analisar a qualidade microbiana de material de acondicionamento de medicamentos e cosméticos disponíveis no mercado brasileiro, no que diz respeito ao cumprimento da legislação, quanto ao nível de contaminação de produtos não estéreis no Brasil. Embalagens de vidro e de plástico foram submetidas à análise microbiológica para verificar a presença de microrganismos viáveis. As embalagens destinadas ao acondicionamento de medicamentos cumprem com o especificado pela RDC 481 de 23/9/1999 da ANVISA, entretanto, as destinadas aos cosméticos não cumprem com tais exigências. O controle de qualidade microbiológico de material de acondicionamento possui importância fundamental, relacionado diretamente com a saúde pública.Several consumers and official agencies, associated with the necessity of more efficient, safety and good microbiological quality packaging materials, conducted to the challenge of having packages which assure both the integrity of products and consumer's health. However, the packaging material can be an important source of microorganisms when does not fulfill the microbiological quality requirements. The objective of this work was to study the microbiological quality of different types of packaging materials for medicines and cosmetics. The microbial quality studies were conducted by analyzing representative samples by bioassay. The packing materials were analyzed for microbiological quality to verify presence of viable microorganisms. They showed the analyzed packaging materials for medicines are in agreement with RDC # 481 on 23/9/1999 of ANVISA. However, the packages to store cosmetic material are not fulfilling this RDC. The microbiological quality control of packing materials has fundamental importance for public health.Colegio de Farmacéuticos de la Provincia de Buenos Aire

Study of physical-chemical stability in contaminated conditioners by bacteria

This work was carried out accelerated stability study that aims to provide data to predict the stability of the product. Emulsions were analyzed with and without preservatives, deliberately contaminated with Staphylococcus aureus and Pseudomonas aeruginosa and samples with no contaminants. The test formulations were subjected to stress conditions to accelerate the emergence of signs of instability. The conditions used were: heating in oven (45 ± 2 ºC), cooling in the refrigerator (5 ± 2 ºC) and room temperature (22 ± 2 ºC). The samples were evaluated at time zero, 24 hours, 7, 15, 30, 60 and 90. We evaluated the organoleptic characteristics (appearance, color and odor) and the physico-chemical (pH, rheological behavior and density). Based on the results obtained in accelerated stability tests, it was observed that the inoculation of microorganisms do not result in significant changes and did not affect the physico-chemical properties, once the samples did not change, even though all situations in which theoretically would facilitate the process of instability. These results reflect the importance of microbiological control of cosmetic products, once the deliberate contamination of creams did not influence the physical stability of the formulation.Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq