A test for corrosivity, i.e. rusting potential for APIs and formulations.

What is it about?

A simple test using meehanite steel test plates from a tablet press turret, petri dishes and a mechanical sieve shaker to simulate the abrasion associated with the abrasion of a tablet press turret made of mehanite steel which results in rusting of the tablet press turret when an acidic drug substance (HCl or sulfate, hemi-sulfate) is compressed in a high RH environment. Particularly a problem during development with consecutive tableting runs or manufacturing runs where complete cleaning does not occur. Validated method.

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Why is it important?

This methodology allows pre-testing of APIs and solid formulations to determine their likelihood of causing rusting of the tabletting equipment. It was used to verify a solution to a rusting formulation. A positive and negative control are used. Acetaminophen the negative/absence of rusting is readily t available. Fenoctamine sulfate is not. However, several generic drugs are given in the publication which are very likely available.