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Total Impurities Calculation

Posted: Tue Nov 25, 2014 11:21 am
by jayroseville58
On Calculation of Total Impurities, Should I include the values generated below LOQ? Thanks.

Re: Total Impurities Calculation

Posted: Tue Nov 25, 2014 12:00 pm
by HPLCaddict
Values below LOQ are by definition "nq", i.e. not quantifiable. There are no values below LOQ!!

Re: Total Impurities Calculation

Posted: Tue Nov 25, 2014 12:40 pm
by Kreall
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.)