ICH Reporting Limit (Related Substance Validation)

[jayroseville58]

I am just wondering what does ICH reporting limit mean particularly on Related Substances Validation.

Thanks.

[Blazer]

The reporting limit is the level at which the impurity needs to be reported. ICH Q3A (Impurities in New Drug Substances) and ICH Q3B (Impurities in New Drug Products) show tables defining the reporting limits which are based on your maximum daily dose of drug substance or drug product, respectively. As this relates to your validation, these documents have statements that the quantitation limit for the analytical procedure should not be more than the reporting threshold.

[jayroseville58]

The reporting limit is the level at which the impurity needs to be reported. ICH Q3A (Impurities in New Drug Substances) and ICH Q3B (Impurities in New Drug Products) show tables defining the reporting limits which are based on your maximum daily dose of drug substance or drug product, respectively. As this relates to your validation, these documents have statements that the quantitation limit for the analytical procedure should not be more than the reporting threshold.

thank you very much blazer