Amoxacillin-Clavulanate Syrup

Scale (g/60 mL volume) Item Material Name Quantity/kg (g) 

Throughout the process of manufacturing and filling, maintain relative humidity of not more than (NMT) 40%. 

Mill 50% of amoxacillin trihydrate, Saccharin sodium (dried to NMT 2% moisture by Karl Fischer method), and succinic acid through a 100 mesh sieve using Fitzmill or equivalent with blades forward. 

Mill remaining amoxacillin trihydrate through a 100 mesh using Fitzmill or equivalent and 

Mill xantham gum, hydroxypropyl methylcel-lulose (dried to NMT 2% mositure dried at 105°C for 2 hours), colloidal silica, and silica gel through a 100 screen using Fitzmill or equivalent with knives forward. Add to above mixture in step 2 and mix for 15 minutes at medium speed. 

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