[RegAffairs]Re: API % Assay Calculation in Commercial Batch

[Surender Kamal <surenderkk@gmail.com>]

Dear Anand G,

Considering the Water content/LOD of the API, Your opinion, that even 
though the % Assay result is > 100% it should be considered as 100% 
is ABSOULTELY CORRECT AND VALID.
I have undergone with such situation earlier and have used the same 
approach as you mentioned.

Thanks

Surender