Impurities in new drug product

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Hello Every one,
In Q3B ich guidelines can any one help me out the exact difference between reporting threshold, identification threshold & qualification threshold ?
Hello.
Reporting th means disregard limit.
Identification th means unidentified impurity limit.
Qualification th means identified impurity limit.
Best regards,
Dmitriy A. Perlow
Sorry I can not understand your point,
if possible could you please elaborate it.
Thank you,
Siva Kumar ch
Hi chunduri.2009,

From ICH Q3B(R2),

http://www.ich.org/fileadmin/Public_Web ... deline.pdf

Degradation Product: An impurity resulting from a chemical change in the drug
substance brought about during manufacture and/or storage of the new drug product by the effect of, for example, light, temperature, pH, water, or by reaction with an excipient and/or the immediate container closure system.

Identified Degradation Product: A degradation product for which a structural
characterization has been achieved.

Unidentified Degradation Product: A degradation product for which a structural
characterization has not been achieved and that is defined solely by qualitative
analytical properties (e.g., chromatographic retention time).

Identification Threshold: A limit above (>) which a degradation product should be identified.

Qualification: The process of acquiring and evaluating data that establishes the
biological safety of an individual degradation product or a given degradation profile at the level(s) specified.

Qualification Threshold: A limit above (>) which a degradation product should be qualified.

Reporting Threshold: A limit above (>) which a degradation product should be
reported.

Appendix 1 of Q3B(R2) contains a plot which may help with explaining these definitions and their relationship.

A caveat can be the toxicity of the degradation product under consideration (upon its qualification).

Please, do you have further specific questions?
MattM
Hi,

I’ve always explained it like this

Reporting threshold: this is the limit at which a peak is to be reported (typically 0.05% relative to sample concentration) basically any peaks greater than 0.05% needs to be calculated and reported as unknowns

Identification threshold: this is the limit where if a peak is observed (typically between 0.1% - 0.2%) you must identify the chemical structure.

Qualification threshold: this is the limit where if a peak is observed (typically greater than 0.2%) you must not only know what the chemical structure is, but you may also have to isolate it and perform a toxicological study or some other study to evaluate if the impurity is toxic or harmful
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