Development and Validation of Stability-Indicating GC-FID Method for the Quantitation of Memantine Hydrochloride and Its Nonchromophoric Impurities in Bulk and Pharmaceutical Dosages

Table 6

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

Sample source	Related substances results				Assay results
	Imp-A	Imp-B	Imp-C	SUMI
Formulation product analysis results
Formulation-1	ND	ND	ND	ND	99.4
Formulation-2	ND	ND	ND	ND	99.9
Batch analysis results (%)
B.NO. MEM/A163/IV/08	ND	ND	ND	0.01	99.7
B.NO. MEM/A163/IV/09	ND	ND	ND	0.01	99.2
B.NO. MEM/A163/IV/10	ND	ND	ND	0.01	99.3

ND: not detected
SMUI: single maximum unknown impurity.