Table 5.

Accelerated stability of the selected VRC-S tablet (F4)

Time (months)	VRC content (%)	Dissolution rate (%)	Degradation products (%)
			Major peak	Total peaks
0	99.4±0.9	93.7±3.7	ND	ND
3	99.9±0.7	93.8±4.1	0.12	0.38
6	100.4±1.4	94.1±3.5	0.15	0.38

Note: Acceptance criteria were set for drug contents of 95%–105%, dissolution rate of >85% in 30 minutes, and degradation products of <0.5% for the major peak and 2.0% for the total peaks in the relative peak area.

Abbreviations: ND, not detected; VRC, varenicline; VRC-S, varenicline salicylate.