Author(s): B. Patil Prashant1, K. More Rupesh2 and G. Khan Zamir2*
The present study provide a high degree of assurance that a specific process for manufacturing of Bethanechol Chloride Tablet 25 mg will consistently produce a product meeting its predetermined specifications and quality attributes. It mainly involves the steps to be followed to evaluate and qualify the acceptability of manufacturing process of Bethanechol Chloride Tablet 25 mg. 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 results were found to be Blend Uniformity results for pre - lubricated blend between 97.3 – 101.8% and for lubricated blend between 94.3 – 101.8 %. Compression assay results between 98 – 103 % were found within acceptable limit. Other test related to compression such as hardness, thickness, disintegration and dissolution for all three batches were found within acceptable limit.