Insulin Injection

Neutral Insulin; Neutral Insulin Injection; Soluble Insulin

(Soluble Insulin Injection, Ph Eur monograph 0834)

Hormone; treatment of diabetes mellitus.

Ph Eur

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

Soluble insulin injection is a neutral, sterile solution of bovine, porcine or human insulin.

A colourless liquid, free from turbidity and foreign matter; during storage, traces of a very fine sediment may be deposited.

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.

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.

Ph Eur