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Total Impurities Calculation

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

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On Calculation of Total Impurities, Should I include the values generated below LOQ? Thanks.
Values below LOQ are by definition "nq", i.e. not quantifiable. There are no values below LOQ!!
Every impurity method should have DL limit incorporated. DL= Disregard limit, limit below which you reject any peaks you have (for many cases the limit is 0,05% of active substance). Ideally LOQ should be equal to or less than the DL. (2.2.46. Chromatographic separation techniques, Ph. Eur.)
3 posts Page 1 of 1

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