RE; drugn product degradent

["rajaneesh.br" <rajaneesh.br@seruminstitute.com> (by way of JohnDolman <info@the-dolman-consultancy.com>)]

Dear Jayakumar,
 
Background: DS may have different impurities (possible and
anticipated) and all of them need not be monitored in the stability study
of DS because all anticipated impurities need not appear in the DS, hence
only degradants are monitored. In case of DP; it is not necessary to
monitor all the impurities of DS, (e.g. process related impurities are
not monitored in DP) instead only degradants are monitored.  
 
Answer for your question is yes and no.
 
Degradants could be same, when (1) two sources of API has same
impurities (2) two sources of API has little different impurity profile
but those different impurities are not acting as degradants in DP,
instead they are just process related impurities. 
 
Degradant could be different: when (1) two sources of API has
different impurities (2) two sources of API has different impurity
profile and those different impurities are acting as degradants in DP.
(3) those different impurities are capable of creating different reaction
products with excipients, container closure systems and drug substance
and this in turn is capable of acting like a degradant.  
 
I hope this is of some use. 
 
Regards,
Rajaneesh.BR