Prospective Process Validation Study of Glibenclamide 2.5 mg Tablets
作者: Prashant B PatilVivekanand K ChatapMahesh P MoreZamir G Khan
作者单位: 1Department of Pharmacy, H. R. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dist: Dhule (MS)- 425 405 India.
刊名: Current Research in Pharmaceutical Sciences, 2018, pp.224-233
来源数据库: Empro Publications
原始语种摘要: The present study provides a high degree of assurance that a specific process for manufacturing of Glibenclamide Tablets will consistently produce a product meeting its predetermined quality attributes and specifications. It mainly comprises the stages to be followed to evaluate and qualify the acceptability of manufacturing process of Glibenclamide 2.5 mg tablets. The process is limited to the three batches manufactured of specific batch size with specified equipments and control parameters for tablets. It involves All parameters related to the each step were evaluated by respective standard test involved in the manufacturing. Sampling, testing plan and acceptance criteria for each step were monitored. The analytical results of all stages were found to be within the acceptable limit....
全文获取路径: Empro出版社 

  • process 过程
  • manufactured 出品
  • three 
  • manufacturing 制造
  • acceptable 可接受的
  • meeting 相遇
  • specific 
  • tablets 平片体
  • control 控制
  • batch 一批