Potassium Clavulanate and Siloid Dioxide 1:1 US

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 suited 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 Silicon Dioxide:
Positive

Assay Clavulanic Acid (on dry basis):
35.9 to 45.0%

Assay Potassium Clavulanate (on dry basis):
42.8 to 53.6%

pH (1%):
4.8 to 8.0

Water:
≤ 2.5%

Related substances: total *:
≤ 1.0%

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 USP

* Related substances relative to the blend