QUALITY CONTROL 2 LEC: this can be done by spiking pure substances (drug substance or drug product) with appropriate levels of impurities and/or excipients and demonstrating that the assay result is unaffected by the presence of these materials (by comparison with the assay result obtained on unspiked samples).

Question

this can be done by spiking pure substances (drug substance or drug product) with appropriate levels of impurities and/or excipients and demonstrating that the assay result is unaffected by the presence of these materials (by comparison with the assay result obtained on unspiked samples).

LEIGHTON DWIGHT OBILLOS · Accepted Answer

Impurities are available

- demonstration of the discrimination of the analyte in
the presence of impurities

QUALITY CONTROL 2 LEC

This can be done by spiking pure substances (drug substance or drug product) with appropriate levels of impurities and/or excipients and demonstrating that the assay result is unaffected by the presence of these materials (by comparison with the assay result obtained on unspiked samples).

Impurities are available - demonstration of the discrimination of the analyte in the presence of impurities

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