Protamine Zinc Insulin Injection

Protamine Zinc Insulin

Antidote to heparin.

Protamine Zinc Insulin Injection is a sterile buffered suspension of bovine, porcine or human insulin complexed with Protamine Sulfate or another suitable protamine and Zinc Chloride or another suitable zinc salt.

The injection complies with the requirements stated under Insulin Preparations and with the following requirements.

Protamine Zinc Insulin Injection is prepared by carrying out the procedures described under Insulin Preparations. A suitable protamine is added in the proportion of 1.0 to 1.7 mg of protamine sulfate per 100 IU of insulin.

A white suspension which on standing deposits a white sediment and leaves a colourless or almost colourless supernatant liquid; the sediment is readily resuspended by shaking. When examined under a microscope, approximately 50% of the particles are seen to have no uniform shape, with a maximum diameter rarely exceeding 2 µm. The remaining particles are seen to be rod-shaped crystals, the majority with a maximum dimension greater than 10 µm but rarely exceeding 100 µm.

In the Assay the position of the peak due to insulin in the chromatogram obtained with the test solution corresponds to that in the chromatogram obtained with the appropriate reference solution.

20 to 25 mg per 100 IU of insulin, determined as described under Insulin Preparations.