[RegAffairs]Analytical method for unspecified & total impurities

["rajaneesh B R" <rajaneesh.br@seruminstitute.com>]

Dear Forum members,

Is it necessary to develop and validate the analytical method for 
determining unspecified and total impurities in the drug product, 
when DP is official in USP and it doesn't contain any such test?
I personally feel it is necessary. Whether any one has different 
opinion with good justification ?

Thanks in advance.

RAJANEESH.BR
Regulatory Affairs