Edition: BP 2025 (Ph. Eur. 11.6 update)
Action and use
Hormone; treatment of diabetes mellitus.
Ph Eur
Soluble insulin injection complies with the monograph Insulin preparations, injectable (0854) with the amendments prescribed below.
DEFINITION
Soluble insulin injection is a neutral, sterile solution of human or porcine insulin.
CHARACTERS
A colourless liquid, free from turbidity and foreign matter; during storage, traces of a very fine sediment may be deposited.
IDENTIFICATION
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.
TESTS
Total zinc
Not more than 40.0 μg per 100 IU of insulin.
Determine by the method described in the monograph on Insulin preparations, injectable (0854).
Use the following test solution.
Test solution Dilute a volume of the gently shaken preparation containing 200 IU to 25.0 mL with water R. Dilute if necessary to a suitable concentration (for example, 0.4 μg to 1.6 μg of Zn per millilitre) with water R.
