Degradant Method for Multi API Product?

[Jenny]

Hello everyone,

What are some strategies to develop degradant method(s) with multi API product?

Please give a hint.

Thanks.

[unmgvar]

do you know your known impurities and degradants at least?
can you get them as standards to work with?
this will help you

other then that the strategy will depend on your compounds themselves

simple things can be done in one method same WL
the more complex then the more different variables, like changing of WL
or 2 methods on 2 completely different columns

[Alera]

It will depend on a lot of variables - like chemistry of your API's, their stability, presence of chromophores, hydrophobic/hydrophilic properties, formulation components etc. You need to provide a lot more info to get a good advice.

[krickos]

Hi

agree with previous answers.

Just to give a much undesireble example that some freinds got stuck with for a new multicomponent drug product.

at least 7 LC methods covering:
-enatiomeric purity/identity as one API is an enantiomer
-2 assay methods
-2 related substances/impurity methods
-2 degradation methods

So if chemistry/chromatography etcetera permits try making it one method.

Sadly my experiance of multicomponents are bit limited but as indicated good chemistry help may be needed as multicomponents may open up for unforseen interactions between degradents/impurities from originating different APIs.