Application of a Validated Stability-Indicating LC Method for the Simultaneous Estimation of Tapentadol and Its Process-Related Impurities in Bulk and Its Dosage Form

Table 3

Results (%) of formulation tablet analysis and bulk drug batch sample analysis.

Sample source	imp-1	imp-2	SMUI
Formulation product analysis results
Formulation 1	ND	0.01	0.02
Formulation 2	ND	0.01	0.07
Batch analysis results (%)
B.NO. TAPE P1001	0.09	0.03	ND
B.NO. TAPE P1002	0.02	0.02	0.05
B.NO. TAPE P1003	ND	0.04	ND

ND: not detected; SMUI: single maximum unknown impurity.