API hold time - Help

The cleaning project I am working on involves an API with little to no stability in our hold time studies. The API degrades immediately to a detectable degradant. We have tried protecting the material from light and evaluating the effects of various extraction solvents but to no avail.

Any recommendations would be greatly appreciated.

My suggestion is to use the degradent as the guideing substance of ensure that the equipment is clean. You need to establish the rate of degradation. Sample and treat the sample such that the entire API has degraded.
I hope this helps.


In my opinion , you mut concern about toxicity of degrade and cleaning limit must calculate by LD50 of degrade , because active ingredient was degrade rapidly (It’s seem to be no residue of API found on surface of equipment after cleaning and hold time.)

No problem … as api degrade to degradant ie it get converted to another molecule if u know the degradant molecule then develop the method by which u can quantify the degradant and apply nessary correction factor. Similarly degrad standard also

thanks you for your post, you help is appreciated:)