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 : 1276 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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