Clavulanate Potassium and Siloid Dioxide 1:1 EU

Formulation:
A powder mixture of clavulanate potassium and silicon dioxide in a 1:1 weight ratio.

Therapeutical category:
The combination of clavulanic acid and amoxicillin can be used against a variety of Beta-lactamase producing Gram positive and Gram negative bacteria. Clavulanic acid enhances the activity of amoxicillin as a broad spectrum antibiotic because of its powerful inhibitory effect on many Beta-lactamase enzymes. Clavulanic acid itself has little useful therapeutic activity.

Application:
The product is suitable for the manufacture of suspensions after addition of appropriate excipients and amoxicillin.

Appearance:
White or almost white powder, hygroscopic.

Identification of potassium clavulanate (HLPC):
Positive.

Identification of potassium:
Positive *.

Identification cellulose:
Positive.

Assay clavulanic acid (on dry basis):
38.5 to 45.0%.

Assay potassiumcClavulanate (on dry basis):
45.8 to 53.6%.

pH (1%):
4.8 to 8.0.

Water:
≤ 2.5%.

Related substances **: total:
≤ 2.0%.

Related substances **: each:
≤ 1.0%.

Related substances **: other detectable impurities:
≤ 0.1%.

Absorbance, 278nm:
≤ 0.40 *.

Bulk density:
≤ 0.60 g/ml.

Tapped density:
≤ 0.85 g/ml.

Shelf life:
5 years

Storage:
In an airtight container, at a temperature below 25º Celsius.

Remark:
Meets the requirements of the latest edition of Ph. Eur.

* Will comply if tested

** Related substances relative to Potassium Clavulanate