Each Extended Release Tablet Contains Paracetamol BP 665 mg.
Sl. | Manufacturing Stages | Parameters for In-Process Checking |
1 | Sieving of Ingredients | Room temperature & Relative humidity Starting time & completion time Mesh size |
2 | Dry Mixing | RPM of mixer Load size Starting time & completion time |
3 | Preparation Binding Fluid | Quantity of binding agent Quantity of fluid Heating temperature of preparation of binding fluid Starting time & completion time |
4 | Wet Mixing | Speed of mixer Direction of mixing blades Starting time & completion time |
5 | Sieving of Wet Mass | Mesh size Starting time & completion time |
6 | Primary Drying | In-let & out-let temperatures of fluid bed dryer Starting time & completion time |
7 | Grinding | Screen size Starting time & completion time |
8 | Final Drying | In-let & out-let temperatures of fluid bed dryer Starting time & completion time Loss on drying of dried granules as per specification |
9 | Sieving of Granules | Room temperature & Relative humidity Mesh size Starting time & completion time |
10 | Blending | Load size of cone blender Speed of blender Starting time & completion time Assay |
11 | Compression | Room temperature & Relative humidity Weight/Tablet adjustment Hardness, thickness, friability & disintegration time Weight variation Starting time & completion time |
12 | Polishing | Room temperature & Relative humidity Starting time & completion time |
13 | Blistering, Printing & Packaging | Room temperature & Relative humidity Inscription of Batch No., Mfg. Date, Exp. Date on blister Leak test Printing of Batch No., Mfg. Date, Exp.Date & M.R.P. on cartons Starting time & completion time |