CMC Strategy
Effects of Residual Carbon Content Matrix on Determining Pharma Regulated Elemental Impurities
Almac Group
CMC Strategy
RCC matrix effects on regulated elements were assessed in this study.
This study assesses RCC matrix effects on regulated elements, comparing external calibration and standard addition by analysing elemental impurities in sucrose using ICP-MS.
This study assesses RCC matrix effects on regulated elements, comparing external calibration and standard addition by analysing elemental impurities in sucrose using ICP-MS.
Matrix Effects
Carbon in the sample can enhance or suppress signal, biasing results.
Calibration Approaches
External calibration and standard addition were compared for accuracy.
Recommendations
Method selection should account for sample carbon content to ensure reliable reporting.
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