Table 1: Bromelain identity and quality control data.

Item profile Specification Result Method Botanical-pineapple Ananas sp. Ananas comosus Visual Plant parts used Mature plant stem Mature plant stem Visual Botanical extract Bromelain Bromelain Maltodextrin diluent Identification Standard Match (Sigma) Conforms to standard HPLC* Activity, potency ≥2400 GDU**/gram 2931 GDU/gram GDU Assay Solvent Residues LOQ‡ Limits USP      Methanol 1000 ppm 3000 ppm <1000 ppm Gas chromatography  Ethanol  1000 ppm 5000 ppm <1000 ppm Gas chromatography  Diethyl ether 2 ppm 5000 ppm <2.0 ppm Gas chromatography  Acetone 50 ppm 5000 ppm <50 ppm Gas chromatography  2-Propanol 200 ppm 5000 ppm <1200 ppm Gas chromatography  Dichloromethane 2 ppm 600 ppm <2.0 ppm Gas chromatography  n-Hexane (C6) 2 ppm 290 ppm <2.0 ppm Gas chromatography  Ethyl acetate 20 ppm 5000 ppm <20.0 ppm Gas chromatography  Xylenes (0, M, P, EB) 1 ppm 2170 ppm ≤1.0 ppm Gas 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 Negative Negative MLP USP 27  Enterobacteriaceae ≤10 CFU/gram <10/gram MLP USP 27  S. aureus Negative Negative MLP USP 27  P. aeruginosa Negative Negative MLP USP 27 Aflatoxin Profile (B1,B2,G1,G2) Aflatoxins ≤20 ppb Negative HPLC Heavy metal profile      Arsenic ≤3 ppm <0.50 ± 0.5 ppm ICP-MS!  Lead ≤10 ppm 0.08 ± 0.05 ppm ICP-MS  Cadmium ≤3 ppm <0.25 ± 0.25 ppm ICP-MS  Mercury ≤2 ppm <0.10 ± 0.1 ppm ICP-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.