ICH Reporting Limit (Related Substance Validation)
Posted: Sun Jul 13, 2014 12:48 pm
I am just wondering what does ICH reporting limit mean particularly on Related Substances Validation.
Thanks.
Thanks.
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ICH Reporting Limit (Related Substance Validation)
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Re: ICH Reporting Limit (Related Substance Validation)
Posted: Mon Jul 14, 2014 3:05 pm
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.
Re: ICH Reporting Limit (Related Substance Validation)
Posted: Tue Jul 15, 2014 5:31 am
thank you very much blazerThe 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.
