Isophane Insulin Injection

Isophane Insulin; Isophane Insulin (NPH)

(Ph. Eur. monograph 0833)

Hormone; treatment of diabetes mellitus.

Ph Eur

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

Isophane insulin injection is a sterile suspension of bovine, porcine or human insulin, complexed with protamine sulfate or another suitable protamine.

Isophane insulin injection is prepared by carrying out the procedures described in the monograph on Insulin preparations, injectable (0854).

The amount of protamine is based on the known isophane ratio and is not less than the equivalent of 0.3 mg and not more than the equivalent of 0.6 mg of protamine sulfate for each 100 IU of insulin in the insulin-protamine complex.

A white or almost white suspension which on standing deposits a white or almost white sediment and leaves a colourless or almost colourless supernatant liquid; the sediment is readily resuspended by gently shaking. When examined under a microscope, the particles are seen to be rod-shaped crystals, the majority with a maximum dimension greater than 1 µm but rarely exceeding 60 µm, free from large aggregates.

Examine the chromatograms obtained in the Assay. The position of the peak due to insulin in the chromatogram obtained with the test solution corresponds to that of the principal peak in the chromatogram obtained with the appropriate reference solution.

Not more than 40.0 µg per 100 IU of insulin, determined as described in the monograph on Insulin preparations, injectable (0854).

Ph Eur