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

Answers were Sorted based on User's Feedback



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)

Is This Answer Correct ?    6 Yes 0 No

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.

Is This Answer Correct ?    0 Yes 0 No

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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