SOFTWARE DEVELOPMENT AND PROCESS VALIDATION IN TABLET MANUFACTURING

Language: English

Published by LAP LAMBERT Academic Publishing Mai 2011, 2011

3844399747 / 9783844399745

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This item is printed on demand - Print on Demand Titel. Neuware -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 Samples were withdrawn from predetermined locations in the mixer at different time intervals 4 to 16 min and assayed spectrophotometrically.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 The samples were withdrawn from different predetermined locations and assayed for Paracetamol content.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 studies and different compression parameters were comply with requirements of I.P. 96. Self developed software Pro-Vali was found to be useful in process validation studies.VDM Verlag, Dudweiler Landstraße 99, 66123 Saarbrücken 136 pp. Englisch.

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Title
SOFTWARE DEVELOPMENT AND PROCESS VALIDATION IN TABLET MANUFACTURING
Author
Dheeraj T. Baviskar
Publisher
LAP LAMBERT Academic Publishing Mai 2011
Publication year
2011
Condition
Neu
Binding
Taschenbuch
Language
English
ISBN 10
3844399747
ISBN 13
9783844399745
Item weight
221 grams
Dimensions
220x150x9 mm

buchversandmimpf2000

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