Identification and Structural Characterization of Unidentified Impurity in Bisoprolol Film-Coated Tablets

Table 4

Results from the TEST software using Ames mutagenicity endpoint with the consensus method.

Prediction results			Individual predictions		Test chemical
Endpoint	Experimental value	Predicted value	Method	Predicted value
(a) Bisoprolol API
Mutagenicity value; Mutagenicity result	N/A; N/A	0.17; Mutagenicity negative	Hierarchical clustering; FDA; Nearest neighbor	0.01; N/A; 0.33
(b) Imp. RRT 0.95
Mutagenicity value; Mutagenicity result	N/A; N/A	0.32; Mutagenicity negative	Hierarchical clustering; FDA; Nearest neighbor	0.42; 0.21; 0.33