Moreover, obtained results indicate the impurity B is <1.1 %; impurities A, C, E, F, G, H, I, L, M, N, O, P <0.2 %; sum of impurities D and J are <0.3 %; any other impurities for each impurity are <0.2 % and total impurities are <1.8%%.
Acceptance criteria's for this analysis is as follows: impurity B must be <2.0 %; impurities A, C, E, F, G, H, I, L, M, N, O, P must be <0.5 %; sum of impurities D and J must be <0.5 %; any other impurities for each impurity must be <0.2 % and total impurities must be <3.0 %.
Table 5 Stability test results of nano-azithromycin that are placed in a relevant tight container for 12 months in RU MED chamber at 30 °C and 65%% RH condition Impurity type Mean: impurity (% w/w) RSD Impurity B 1.1 0.02 Impurities A, C, E, F, G, H, I, L, M, N, O, P 0.2 0.05 Sum of impurities D and J 0.3 0.10 Any other impurities 0.2 0.02 Total impurities 1.8 0.1.8
The idea is to split the original group into two sub-groups in such a way that impurity decreases in a maximal way, i.e., that the sum of impurities of sub-groups is minimized.
The proposed method is able to identify and quantify the sum of all impurities occurring in the preparation, respecting the acceptance criteria for the radiochemical purity defined by the official methods.
Setting the limit to 3% for the sum of the impurities on strip 2 (99mTc-precomplexes, 99mTc-tartrate and (99mTcO2)n) enables us to respect the 2% for the colloidal form (99mTcO2 n.
The second importance measure is the Gini importance of a variable and is calculated as the sum of the Gini impurity decrease of every node in the forest for which that variable was used for splitting.
Each SPC method requires detection of the sum of liphophilic and hydrophilic impurities Ph.Eur.
Each method requires detection of the sum of liphophilic and hydrophilic impurities, except for the Rotop method from 2016 (only available for EU countries) where detection of colloidal 99mTc ((99mTcO2)n) as an individual impurity is specified and acceptance criteria are set separately Ph.Eur.
In each case the relative standard deviations (RSD) of the peak area of an identified impurity peak, normalized to the sum of the area of the "target impurities" suggested in the CHAMP profiling method, was assessed.
To this end, we calculated the sum of all decreases in Gini impurity for each cluster in the vacuum model.
