Table 1: Bromelain identity and quality control data.

Item profileSpecificationResultMethod

Botanical-pineappleAnanas sp.Ananas comosusVisual
Plant parts usedMature plant stemMature plant stemVisual
Botanical extractBromelainBromelainMaltodextrin diluent
IdentificationStandard Match (Sigma)Conforms to standardHPLC*
Activity, potency≥2400 GDU**/gram2931 GDU/gramGDU Assay
Solvent ResiduesLOQ Limits USP
 Methanol1000 ppm 3000 ppm<1000 ppm Gas chromatography
 Ethanol 1000 ppm 5000 ppm<1000 ppm
Gas chromatography
 Diethyl ether2 ppm 5000 ppm<2.0 ppmGas chromatography
 Acetone
50 ppm 5000 ppm<50 ppmGas chromatography
 2-Propanol
200 ppm 5000 ppm<1200 ppmGas chromatography
 Dichloromethane
2 ppm 600 ppm<2.0 ppmGas chromatography
 n-Hexane (C6)
2 ppm 290 ppm<2.0 ppm
Gas chromatography
 Ethyl acetate 20 ppm 5000 ppm<20.0 ppmGas chromatography
 Xylenes (0, M, P, EB)1 ppm 2170 ppm≤1.0 ppmGas chromatography
Microbial Profile(CFU/gm)(CFU/gm)
 Total mold and yeast
≤300/gram
160
MLP° USP 27
E. coli Negative
Negative
MLP USP 27
Salmonella NegativeNegative
MLP USP 27
Enterobacteriaceae ≤10 CFU/gram<10/gram
MLP USP 27
S. aureus NegativeNegative
MLP USP 27
P. aeruginosa NegativeNegativeMLP USP 27
Aflatoxin Profile
(B1,B2,G1,G2)
Aflatoxins ≤20 ppbNegativeHPLC
Heavy metal profile
 Arsenic
≤3 ppm<0.50 ± 0.5 ppm ICP-MS!
 Lead
≤10 ppm0.08 ± 0.05 ppmICP-MS
 Cadmium
≤3 ppm <0.25 ± 0.25 ppmICP-MS
 Mercury≤2 ppm<0.10 ± 0.1 ppmICP-MS

HPLC: high-performance liquid chromatography, **GDU’s: gelatin dissolving units; LOQ: limit of quantification, °microbial limit tests; ! ICP-MS: inductively coupled plasma-mass spectrometry; #CDFA: California Department of Food and Agriculture.