Amoxicilin trihydrate and potassium clavulanate tablet mixture 4:1

Appearance:  white to slightly yellowish powder

Identification

Amoxicillin(HPLC): corresponding

Clavulanic acid(HPLC): corresponding

Water: 9.2-11.0%

Related substances(HPLC)

degration products, by-products and unknown related substances

Single: not more than 2.0%

Total: not more than 5.0%

Residual solvents (GC)

isopropyl alcohol: not more than 0.5%

butyl acetate: not more than 0.5%

n-butyl alcohol: not more than 0.5%

pH: 4.8-8.6

Assay:

Amoxicilin (HPLC, anhydrous basis): not less than 73.2%

Clavulanic acid (HPLC, anhydrous basis): not less than 17.4%

Ratio amoxicilin/clavulinic acid (HPLC): 3.7-4.3 (m/m)