Table II.

Results of Medication Related Compounds Assays

Medication	Method	Criteria	Results per sample
Loratadine	USP monograph: Loratadine tablets	Individual NMT 0.1%	RRT	A	B	C	D
		Total NMT 0.1%	0.40	ND	ND	0.01	ND
			1.35	0.03	0.03	0.03	0.03
			1.96	0.02	0.03	0.03	0.03
			Tot	0.05	0.06	0.07	0.06
Melatonin	Dietary supplement: Melatonin tablets	Individual NMT 0.1%	RRT	A	B	C	D	E
		Total NMT 1.0%	1.13	0.08	ND	0.08	0.08	0.08
			1.97	0.16	0.16	0.16	0.16	0.16
			2.04	0.06	0.06	0.06	0.06	0.06
			2.11	0.12	0.11	0.12	0.12	0.11
			2.15	0.08	0.08	0.08	0.08	0.10
			2.17	0.06	0.06	0.06	0.06	0.06
			2.22	0.06	0.06	0.05	0.05	0.05
			2.24	0.14	0.14	0.14	0.14	0.14
			2.61	0.10	0.11	0.11	0.10	0.09
			Tot	0.96	0.77	0.88	0.85	0.84

Assays were USP-related Compounds (% w/w) for each medication. USP criteria are no more than (NMT) 0.1% by weight for individual compounds in either medication. In the case of melatonin, an amount of related compounds up to a total of 1.0% by weight is acceptable, but for loratadine the total limit is the same as the individual limit, 0.1%. Relative retention time (RRT) is used to define each peak (listed vertically under “Results per sample”), with each different sample identified by A–E. Results are given in % w/w

ND not detectable