Impurities in new drug product - Chromatography Forum

Impurities in new drug product

Discussions about HPLC, CE, TLC, SFC, and other "liquid phase" separation techniques.

4 posts Page 1 of 1
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
4 posts Page 1 of 1

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