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J Parenter Sci Technol ; 45(2): 88-93, 1991.
Artículo en Inglés | MEDLINE | ID: mdl-2051262

RESUMEN

A collaborative study was undertaken to determine the potency in endotoxin Units (EU) and International Units (IU) of a control standard endotoxin, LIF-1. Five laboratories from the Swedish Pharmaceutical Industry participated in the study. As reference preparations, two official standards, USP reference standard endotoxin, EC-5 (expressed in EU) and WHOs international standard endotoxin (expressed in IU), were used. The study was performed using the Limulus Amebocyte Lysate (LAL), gel-clot test. The test protocol included dilutions of the endotoxin in steps of 1:1.25 instead of the conventional 1:2 step dilution method. This gave more precise and standardized results. The content of one vial of LIF-1 (CSE) was calculated to be 22 EU and 16 IU which indicates that 1 EU (USP) corresponds to 0.7 IU (WHO).


Asunto(s)
Contaminación de Medicamentos/prevención & control , Industria Farmacéutica/normas , Endotoxinas/análisis , Contaminación de Equipos/prevención & control , Prueba de Limulus , Estándares de Referencia , Suecia
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