Citas bibligráficas
Flores, J., (2002). Validación concurrente del proceso de Fabricación de tabletas recubiertas de amoxicilina 500 mg [Tesis, Universidad Nacional Mayor de San Marcos]. https://hdl.handle.net/20.500.12672/929
Flores, J., Validación concurrente del proceso de Fabricación de tabletas recubiertas de amoxicilina 500 mg [Tesis]. PE: Universidad Nacional Mayor de San Marcos; 2002. https://hdl.handle.net/20.500.12672/929
@misc{renati/1225935,
title = "Validación concurrente del proceso de Fabricación de tabletas recubiertas de amoxicilina 500 mg",
author = "Flores Jaime, Juliana",
publisher = "Universidad Nacional Mayor de San Marcos",
year = "2002"
}
-- In the present study of thesis, a concurrent validation of the Process of Manufacture of tablets coated with 500 mg Amoxiciline was performed in order to establish a well documented evidence of a process capable of fulfill, in a consistent and repetitive way, the established specifications. A concurrent validation protocol was performed for which three consecutive standard batches were used. Everyone was evaluated in granulation, compression and coating phases. The granulation phase was divided in two, the first, before the lubrication, in which the trials of the compound of the active component, and the excipients, size of the granule and apparent density were performed. The second, after the lubrication, in which the trials of compound of the active component, excipients and lubricant, size of granule, apparent density, angle of rest, and content of water were performed. In the compression phase, trials of appearance, dimension, variation of weights, concentration of the active component, uniformity of the active component content, dissolution, desintegration, friability, hardness and water content were performed. In the coating phase, trials of appearance, dimension, variation of weights, concentration of the active component, uniformity of the active component content, dissolution and water content were performed. For weight and hardness evaluation X-R control graphics were used. After determining these control graphics, calculation of the Cp index of capacity and Cpk index were performed, verifying the fulfillment of the process with the established specifications.
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