software development process validation von baviskar dheeraj (8 Ergebnisse)

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Taschenbuch. Zustand: Neu. This item is printed on demand - it takes 3-4 days longer - 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 Samples were withdrawn from predetermined locations in the mixer at different time intervals 4 to 16 min and assayed spectrophotometrically.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 The samples were withdrawn from different predetermined locations and assayed for Paracetamol content.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. 136 pp. Englisch.

Zustand: New. Print on Demand pp. 136 2:B&W 6 x 9 in or 229 x 152 mm Perfect Bound on Creme w/Gloss Lam.

Zustand: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Autor/Autorin: Baviskar Dr. Dheeraj T.Dr. Dheeraj T. Baviskar, M.Pharm, Ph.D.,D.B.M., A.I.C studied Post Doctarate (2010), Ph.D. (2007) and M.Pharm (Quality Assurance, 2000). Professor and Principal at Institute of Pharmaceutical Education, Bora.

Zustand: New. PRINT ON DEMAND pp. 136.

Taschenbuch. Zustand: Neu. 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 Samples were withdrawn from predetermined locations in the mixer at different time intervals 4 to 16 min and assayed spectrophotometrically.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.

Taschenbuch. Zustand: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - 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.