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Como se Calibra un Disolutor

Pregunta de Clase de Tecnología Farmaceutica
by Cristian Paredes on 26 June 2010

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Transcript of Como se Calibra un Disolutor

¿Cómo se calibra un Disolutor? Pontificia Universidad Católica de Chile
Facultad de Química - Departamento de Farmacia
Tecnología Farmacéutica II
Cristian Paredes Kunst
Profesor: Pablo González Considera dos aspectos Mecánico Idoneidad USP define parámetros de instalación y calibración cómo:

Vaso
Tamaño de Canasto o Paletas
Alineamiento Vertical del Eje
Bamboleo del Eje del Canasto o Paletas
Centrado delEje con el Vaso
Profujndidad de las Paletas o Canasto
Velocidad de Vibración Rotacional
Temperatura media del Vaso

Que afectan la hidrodinámica al interior del vaso

Calibrador de Disolución Tipo No-Desintegrante Tipo Desintegrante Procedure- [See DISSOLUTION <711> and DRUG RELEASE <724> in the current USP.]
Determine the quantity of prednisone, C21H26O5, dissolved at thirty minutes, in each vessel,
expressed as percent of the labeled amount. Use 500 mL of deaerated water as the
Dissolution medium and conduct the test at 37°. Operate each apparatus at 50- rpm speed.
Measure the amount of prednisone dissolved from filtered portions of the sample aliquots
withdrawn at thirty minutes, at the wavelength of maximum absorbance at about 242 nm in
comparison with a solution of known concentration of USP Prednisone Reference Standard. Procedure- [See DISSOLUTION <711> and DRUG RELEASE <724> in the current USP.] Determine the
quantity of salicylic acid, C7H6O3, dissolved at thirty minutes, in each vessel, expressed as percent of the
labeled amount. Use 900 mL of 0.05M Phosphate Buffer pH=7.4 ± 0.05 (pH tested at room temperature)
as the Dissolution Medium and conduct the test at 37°. Operate each apparatus at 100-rpm speed.
Measure the amount of salicylic acid dissolved from filtered portions of the sample aliquots withdrawn and
suitably diluted with Dissolution Medium if necessary at 296 nm (the approximate wavelength of
maximum absorbance) in comparison with a solution of known concentration of USP Salicylic Acid
Reference Standard. Fuentes de Error en Calibración Desgasación
Vasos
Vibración y problemas mecánicos
Automatización
Comprimidos
Estándar de Referencia
Filtrado
Canastos y Paletas
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