Product:        Potassium Clavulanate   C₈H₈KNO₅

Test

Limits

Description

Solubility

Identification

PH

Optical rotation

Absorbance:

Related substances HPLC

1,1-Dimethylethylamine

Potassium clavam-2-carboxylate

Water

ASSAY

A white or almost white, crystalline powder, hygroscopic.

 Freely soluble in water, slightly soluble in alcohol, very slightly soluble in acetone.

A.       Infrared spectrophotometry, as same as reference spectrum of potassium Clavulanate.

B.       Potassium positive

1% solution 5.5 to 7.5.

+53° to +63°,

The absorbance at 278 nm is not greater than 0.40

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%.

Not more than 0.2 per cent

Not more than 0.01 per cent

Not more than 0.5 per cent

96.5 - 100.5 %

This material has been prepared following the good manufacturing practice (G.M.P.) and conforms above specification & requirements of BP2000