Biological Safety Studies and Simultaneous Determination of Linagliptin and Synthetic Impurities by LC-PDA

Table 5

Results of potential risk to cause toxicity for linagliptin and impurities 1 to 3.

Toxicity risk	pKCSM	Osiris	LAZAR
Mutagenicity
LGT	+	−	−
IMP 1	+	−	−
IMP 2	+	+ (Low)	+
IMP 3	−	−	−
Carcinogenicity
LGT	NC	−	−
IMP 1	NC	−	−
IMP 2	NC	+ (High)	+
IMP 3	NC	−	−

NC: software does not calculate this property. Results are expressed as positive (+) or negative (−) and high, medium, and low for Osiris Property Explorer.