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VALORACI"N DE ENDOTOXINAS BACTERIANAS EN RANITIDINA Y PENICILINA G S"DICA INYECTABLE MEDIANTE LA PRUEBA DE LISADO DEL AMEBOCITO DE Limulus

2006; Pontifical Xavierian University; Volume: 11; Issue: 1 Linguagem: Inglês

2027-1352

Carolina Carrillo, Javier Ospina, Diana Cristina Arias Aldana, Janeth Arias, Carlos Andrés Giraldo Echeverri,

Pediatric health and respiratory diseases

The standardization and evaluation of bacterial endotoxins by the Limulus amebocyte lysate (LAL) test was carried out for two injectable pharmaceutical products: sodium penicillin G and ranitidine using the Gel-Clot technique. For this process, three samples were taken from three different lots; the samples were chosen at random and a sample was taken from the beginning, the midpoint and again at the end of the production of every lot sampled. The samples from each lot were pooled, thus leaving three sub lots to analyze, giving greater trustworthiness to the method. The sensitivity of the LAL reagent (0,25 UE/ml) was verified on behalf of the worker in order to obtain reliable results. The endotoxin limits for Sodium Penicillin G, 0,01UE/100 UI, and Ranitidine, 7UE/mg, were determined by consulting USP XXVI. The maximum valid dilution (MDV) was calculated to be 1:400 and 1:700 respectively; the preliminary assays employed (Unspike and Spike) determined the working dilution for penicillin, 1:100, and ranitidine, 1:200. With the final assay the presence of bacterial endotoxins was evaluated in both injectable products.