Why we are injecting low load standard conc. while analysing Related Substances by HPLC?

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Why we are injecting low load standard conc. while analysing Related Substances by HPLC?..

Answer / rajkumar

It is the concentration of the Unknown impurity which comes
from the reporting threshold. For any query see ICH Q3B(R2)

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Why we are injecting low load standard conc. while analysing Related Substances by HPLC?..

Answer / ravi kumar tummala

yes, we r injecting std injection at low concentrtion,one reason is impurity specification level and another one is to calculate the imp's against std area.

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Why we are injecting low load standard conc. while analysing Related Substances by HPLC?..

Answer / sri

It is at impurity specification limit

Is This Answer Correct ?    0 Yes 1 No

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