Answer / christian

If you are talking about impurities in API (active
pharmaceutical ingredient), requirement are described in
ICH guideline.

This refer to impurity with structure similar to the one of
the API coming classicaly from:

Isomers, Enantiomer, Hydrolysis (acid ou basic, and water)

Oxydation, overreaction , raw material impurities,
intermediates(N-1, N-2..), dimer, light degradation...



All impurities detected by HPLC at a level over 0.1 % have
to be identified (characterized: means structure elucidated
by NMR, Mass spectra...).



For more détails visit my website dedicated to chemical and
process development for pharmaceuticals: www.synthorga.fr

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