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SOFTWARE DEVELOPMENT AND PROCESS VALIDATION IN TABLET MANUFACTURING


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Год выпуска: 2011
Автор: Dr. Dheeraj T. Baviskar and Dr. D. K. Jain
Издательство: LAP Lambert Academic Publishing
Страниц: 136
ISBN: 9783844399745
Описание
 The quality of the final product especially with respect to the content of uniformity is primarily determined by homogenicity of mixture. Validation of process has become mandatory in U.S. as per GMP regulations and also by a court action of 1993. Present study involves validation of mixing, drying and compression process for the manufacturing of Paracetamol Tablet I.P.(500 mg) Paracetamol was mixed with starch in a mass mixer as per the developed formula. Samples were withdrawn from predetermined locations in the mixer at different time intervals 4 to 16 min and assayed spectrophotometrically. The dried granules were mixed with lubricants consisting of Talcum, Magnesium Stearate and Sodium Lauryl Sulphate. The samples were withdrawn from different predetermined locations and assayed for Paracetamol content. From analysis of data that 10 min was found to be optimum mixing time during mixing process. Time required for 3 Kg of material was 29 to 30 minutes for drying...

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