FAQ
Drugs

The analytical method of related substances for drug substance is by HPLC. Is it necessary to prepare the standard solution with the same concentration as that of 100% impurity specification?

刊登日期:2019-11-22  |  點閱次數 : 1480 次 

No. It is not necessary to prepare the standard solution with the same concentration as that of 100% impurity specification if linear relationship is justified across the range.

Linear relationship:

The linearity of an analytical procedure is its ability (within a given range) to obtain test results that are directly proportional to the concentration (amount) of analyte in the sample.

 

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