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SOFTWARE DEVELOPMENT AND PROCESS VALIDATION IN TABLET MANUFACTURING

  • Couverture cartonnée
  • 136 Nombre de pages
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The quality of the final product especially with respect to the content of uniformity is primarily determined by homogenicity of m... Lire la suite
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Description

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 Samples were withdrawn from predetermined locations in the mixer at different time intervals 4 to 16 min and assayed spectrophotometrically.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 The samples were withdrawn from different predetermined locations and assayed for Paracetamol content.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.

Auteur

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, Boradi,Tal- Shirpur, Dist-Dhule,(M.S.)India. Twelve years experiance at UG & PG level. Approved Supervisor for PG & Ph.D. students.

Informations sur le produit

Titre: SOFTWARE DEVELOPMENT AND PROCESS VALIDATION IN TABLET MANUFACTURING
Sous-titre: Process Validation
Auteur:
Code EAN: 9783844399745
ISBN: 978-3-8443-9974-5
Format: Couverture cartonnée
Editeur: Dictus Publishing
Genre: Médecine
nombre de pages: 136
Poids: 219g
Taille: H220mm x B150mm x T8mm
Année: 2011