- British Pharmacopoeia Volume III
- Formulated Preparations: Specific Monographs
Biphasic Isophane Insulin Injection |
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Biphasic Isophane Insulin
(Ph. Eur. monograph 0832)
Hormone; treatment of diabetes mellitus.
Ph Eur
Biphasic isophane insulin injection complies with the monograph on Insulin preparations, injectable (0854) with the exception of the test for Insulin in the supernatant and with the amendments prescribed below for the other tests.
Biphasic isophane insulin injection is a sterile buffered suspension of either porcine or human insulin, complexed with protamine sulfate or another suitable protamine, in a solution of insulin of the same species.
Biphasic isophane insulin injection is prepared by carrying out the procedures described in the monograph on Insulin preparations, injectable (0854).
Biphasic isophane insulin injection is produced by mixing, in defined ratios, soluble insulin injection and isophane insulin injection. The defined ratios shall be demonstrated by a test method which has been approved by the competent authority to comply with the label claim.
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 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).
The label states in addition to the indications mentioned in the monograph on Insulin preparations, injectable (0854) the ratio of soluble insulin injection to isophane insulin injection used in the manufacturing process of biphasic isophane insulin injection.
Ph Eur