By Anonymous on Monday, June 2, 2003 - 05:08 am:
Hallo everyone
How exactly do you “spike” your final product (ointment, cream) with impurities for validation purposes?
I know this is a very simple question, but could someone, please, spare a few minutes?
By Anonymous on Monday, June 2, 2003 - 04:33 pm:
Hello
For eg-- Final product( Drug) con.c 1000ug/ml this IS 100%
+
Imp-1-- 5ug (0.5%)
Imp-2-- 5ug (0.5%)
Imp-3-- 5ug (0.5%)
mix them Inject it
for Resolution Std-- 0.05%(0.5ug/ml)
if you have any questions don't hesitate
good luck