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Answer:

Unless otherwise prescribed or justified and authorised, organic impurities in active substances are to be reported, identified wherever possible, and qualified as indicated in the general monograph Substances for pharmaceutical use (2034) (Table 2034.-1 or Table 2034.-2).

Generally, specified impurities have their own specific acceptance criterion in the individual monograph. For other impurities, the decision tree in general chapter 5.10. Control of impurities in substances for pharmaceutical use may be used to determine the applicable acceptance criterion.

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