CAS No.:34642-77-8

TOXICITY DATA with REFERENCE：

 

Consensus Reports：

 

SAFETY PROFILE：

 

Standards and Recommendations：

Identification(HPLC): corresponding
Water content(Karl Fischer): not more than 2.0 %
visible particles: essentially free
subvisible particles: particles >= 10 μm: <= 6000/g; particles >= 25 μm: <= 600/g
pH: 8.0 - 10.0
2-Ethylhexanoic acid: not more than 0.8 %
Sterility: sterile
Bacterial endotoxins: not more than 0.03 IU
related substances: Individual: not more than 2.0 %; Dimer: not more than 3.0 %; Total: not more than 9.0 %
Assay/Content(HPLC): Clavulanic acid: 7.4 - 9.02 %; Amoxicillin: 73.8 - 90.2 %
Ratio: Amoxicillin/Clavulanic acid: 9.0 - 11.0 (w/w)

Analytical Methods：