Cleaning validation

I did read the pharmaguideline article about concentration of API (Identification of Worst Case in Cleaning Validation). It says the product having higher API concentration is the worst-case.

Hipothetical Example:
Some medicine has paracetamol api 500 mg plus other api maleate of chlorfeniramine 4 mg. So is the worst case the paracetamol api ? I tried to find ich cleaning guide, gmp cleaning guide. They don’t say nothing about higher api concentration for worst-case how do we assume that ? I’m studying about this topic and i got very curious. Thanks.

It is better to put the link of the mentioned article

Sure my bad.

1 Like

I saw what is in the link

I think the link “in point 5” is comparing between products having “the same API”

Kind regards

Hi, Can any one suggest the rationale for selection of rinse solvent used for establishing recovery factor in QC & Plant equipment.