Potassium Clavulanate and Microcrystalline Cellulose 1:1 China

Formulation:
A powder mixture of Potassium Clavulanate and extra dry microcrystalline cellulose 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 tablets after addition of appropriate excipients and amoxicillin.

Appearance:
White to almost white powder, odorless.

Identification of potassium clavulanate (HLPC):
Positive.

Identification potassium:
Positive *.

Identification cellulose:
Positive.

Assay clavulanic acid (on dry basis):
≥ 40.0%.

pH (1%):
5.5 to 8.0.

Water:
≤ 1.5%.

Acetone:
≤ 0.3%.

Bulk density:
≤ 0.50 g/ml.

Tapped density:
≤ 0.70 g/ml.

Shelf life:
3 years.

Storage:
In an airtight container, at a temperature below 15º Celsius.

Remark:
Meets the requirements of the Import Drug Licence.

* Will comply if tested