By Kirstin on Friday, April 25, 2003 - 04:57 am:
What accuracy / recovery rate is generally accepted for impurities (drug product) in the range of limit of quantitation (0,1 %)?
By Anonymous on Saturday, April 26, 2003 - 12:43 am:
LOQ have to be < = 0.05%!! Accuracy between 50-150%, precision < 25%
By Kirstin on Monday, April 28, 2003 - 12:54 am:
Thanks for the quick answer!! Do you know if there is any literature / guidance to support this criteria for the LOQ ?
Best regards
Kirstin
By Anonymous on Tuesday, April 29, 2003 - 06:25 am:
Monografía AEFi, Usp ...
By Alex on Tuesday, April 29, 2003 - 06:44 am:
Hi, you will not find any exact criteria for drug products.
Thats o.k. because dp are diverse and as soon as someone would state exact values people would take this for granted. There are aspirin tablets with 500 mg/tablet and there are other drug products with 0.25 µg/tablet. Would you like to use the same acceptance criteria?
On the other hand some values would be usefull for benchmarking the own work.
Accuracy 50-150% and precision <25% can be used, but from my feeling you will need a good justification. According to Horwitz one would expect at 0.1 %a RSD of 5.66% and the accuracy should be 80-120% (at 0.01 % it ist still 7.91% and something like 70-130%)
By Alex on Tuesday, April 29, 2003 - 10:39 pm:
Kirstin, criteria for LOQ can be found in the ICH guideline Q3b.
The new European Pharmacopoiea will state as system suitability criterium for impurity tests 5% RSD max (thats than precision). Again, the recovery range should not be more than three or four times bigger.