Hi everyone,
Thanks for the great exchange here, very valuable!
Another question concerning the limit of nitrosamines (not API related!) in drug products; I think it was also mentioned by @sameer here: [Calculation of limit when more than one nitrosamine is identified - #9 by sameer]
How would you determine the MDD to calculate the limit in multiple-API products?
Suggestions:
a) highest MDD of all APIs (e.g. MDD 1 = 10mg, MDD 2 = 20 mg, MDD multiple = 20 mg)
b) the sum of all MDDs (worst case?, e.g. MDD 1 = 10mg, MDD 2 = 20 mg, MDD multiple = 30 mg)
c) any other?
For API-derived nitrosamines, the MDD of the corresponding API would be appropriate; I am just wondering how to proceed with API-non-related nitrosamines.
I would appreciate any feedback