O
omviki
Hi, I am doing the HPLC Impurity Method Transfer to the contract lab.
As per method transfer protocol I made six preparations from a single lot of API sample, but Impurity xyz % RSD (six impurity preps) failed 17% (spec 15%).
Interesting thing here is only %RSD of impurity xyz failed but imprity xyz is still within the spec 0.2% (spec. is <0.25%) as per Certificae of Analyis (COA).
Should i initiate the oos investigation ?
or Repeat the whole testing by making six preps and if % RSD passe then just mention in the method trasfer report that %RSD WAS NOT ACHIEVED SO TESTING WAS REPEATED.
i think sample %RSD Failure is not an OOS investigation.
As per method transfer protocol I made six preparations from a single lot of API sample, but Impurity xyz % RSD (six impurity preps) failed 17% (spec 15%).
Interesting thing here is only %RSD of impurity xyz failed but imprity xyz is still within the spec 0.2% (spec. is <0.25%) as per Certificae of Analyis (COA).
Should i initiate the oos investigation ?
or Repeat the whole testing by making six preps and if % RSD passe then just mention in the method trasfer report that %RSD WAS NOT ACHIEVED SO TESTING WAS REPEATED.
i think sample %RSD Failure is not an OOS investigation.