TABLE 5.

Concentration of quantified chemical elements (µg/g) in herbal medicines compared with permitted concentration of elements impurities for individual component option established by USP (USP, 2021) and FB (Agência Nacional de Vigilância Sanitária/Fundação Oswaldo Cruz, 2010).

Elements	Pasalix® (µg/g)	Calman® (µg/g)	Serenus® (µg/g)	Prakalmar® (µg/g)	Calmasyn® (µg/g)	Maracugina® (µg/g)	Permitted concentration of elements impurities for individual component option (oral concentration-USP) (µg/g)	Permitted concentration of elements impurities (oral concentration-BF**) (µg/g)
As	1.30 ± 0.3	1.10 ± 0.4	1.30 ± 0.08	1.70 ± 0.3	1.40 ± 0.09	1.50 ± 0.008	1.5	1.5
Ba	1.20 ± 0.06	0.110 ± 0.01	< LOD	0.180 ± 0.009	0.300 ± 0.001	3.90 ± 0.11	140	—
Cd	0.010 ± 0.002	< LOD	0.050 ± 0.009	0.00700 ± 0.001	0.060 ± 0.01	0.070 ± 0.01	5*	0.5
Co	0.610 ± 0.017	0.610 ± 0.01	0.920 ± 0.06	0.560 ± 0.02	0.790 ± 0.03	0.810 ± 0.03	5	—
Cr	0.380 ± 0.02	0.210 ± 0.02	0.610 ± 0.02	0.560 ± 0.04	0.380 ± 0.008	0.680 ± 0.03	1,100	25
Cu	1.50 ± 0.08	0.710 ± 0.02	0.610 ± 0.01	4.10 ± 0.04	3.60 ± 0.06	1.50 ± 0.005	300	250
Fe	16.4 ± 0.5	8.20 ± 0.2	1,200 ± 27.9	36.8 ± 3.4	15.3 ± 1.2	123 ± 2.6	NA	400
Pb	1.40 ± 0.01	0.940 ± 0.16	1.50 ± 0.007	1.50 ± 0.02	1.50 ± 0.02	1.70 ± 0.08	0.5	1.0

< LOD - analyte concentrations were below the limits of detection. *New values for Cadmium established in Ref. (European Medicines Agency, 2019). **Brazilian Pharmacopeia, 2010 (ANVISA, 2010) (Agência Nacional de Vigilância Sanitária/Fundação Oswaldo Cruz, 2010).

NA = Not Applicable.