|
Test |
Limits |
|
Description
|
A white or almost white, crystalline powder, hygroscopic.
|
|
Solubility
|
Freely soluble in water, slightly soluble in alcohol, very slightly soluble in acetone.
|
|
Identification
|
A. Infrared spectrophotometry, as same as reference spectrum of potassium Clavulanate.
B. Potassium positive
|
|
PH
|
1% solution 5.5 to 7.5.
|
|
Optical rotation
|
+53° to +63°,
|
|
Absorbance
|
The absorbance at 278 nm is not greater than 0.40
|
|
Related substances HPLC
|
The area of any peak apart from the principle peak is not grater than 1.0%, the sum of such area not grater than 2.0%.
|
|
1,1-Dimethylethylamine
|
Not more than 0.2 per cent
|
|
Potassium clavam-2-carboxylate
|
Not more than 0.01 per cent
|
|
Water
|
Not more than 0.5 per cent
|
|
ASSAY
|
96.5 - 100.5 %
|