What is the difference between specified impurity and
Identified impurity
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Answer / sanjay prajapati
individual impurities with a specific acceptance criterion that are included in the specification for a drug substance are referred to as specified impurities. Specified impurities can be identified or unidentified.
identified impurity : for those impurities whose chemical structure are known
Is This Answer Correct ? | 9 Yes | 2 No |
Answer / asha latha
Specified impurity is having path formed from api but identified impurity may not have a path
Is This Answer Correct ? | 5 Yes | 8 No |
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hii, i'm had a sample of 1L that gone through extraction & evaporation. i used 0.5ml of methanol for reconstitution before injecting the sample to HPLC. i made a calibration curve using a standard solution but now i'm confused about how to display the concentration i got from the sample. for ex. i got 0.2ug/ml how i'm gonna explane this is for the 1L ? please help .. i'll really appreciate it thanks