Amoxicillin/Clavulinate Potassium 5:1

Apperance: white to almost white crystalline powder

Solubility in water: freely soluble

Paticulate matter:

   Greater than 10 μm: < 6000/gram

   Greater than 25 μm < 600/gram

pH(10% w/v): 8.0-10.0 

Water(K.F.)%: not more than 2.0%

2-Ethylhexanoic acid: not more than 0.8%

Assay(HPLC)

   Amoxicillin as acid: 67.5-82.5%

   Clavulanic acid as acid: 13.5-16.5%

Ratio Amoxicilin/Clavulanic aicd: 4.5-5.5 (w/w)

Bacterial endotoxins: < 0.03% UE/mg

Sterility: sterile

Residue solvents:

   Ethanol < 0.5%

   Acetone < 0.3%

   Methyl acetate < 0.5%