Biphasic Insulin Injection

Biphasic Insulin

(Ph. Eur. monograph 0831)

Hormone; treatment of diabetes mellitus.

Ph Eur

Biphasic insulin injection complies with the monograph on Insulin preparations, injectable (0854) with the amendments prescribed below.

Biphasic insulin injection is a sterile suspension of crystals containing bovine insulin in a solution of porcine insulin.

A white or almost white suspension. When examined under a microscope, the majority of the particles are seen to be rhombohedral crystals, with a maximum dimension measured from corner to corner through the crystal greater than 10 µm but rarely exceeding 40 µm.

Examine the chromatograms obtained in the assay. The position of the peaks due to the two insulins in the chromatogram obtained with the test solution correspond to those of the principal peaks in the chromatogram obtained with the appropriate reference solution.

The pH of the suspension to be examined is 6.6 to 7.2.

22.0 per cent to 28.0 per cent of insulin in solution. Determine by the method described in the test for insulin in the supernatant in the monograph on Insulin preparations, injectable (0854).

26.0 µg to 37.5 µg per 100 IU of insulin. Determine by the method described in the monograph on Insulin preparations, injectable (0854)

Ph Eur