Items Specifications Results Identification INFRARED ABSORPTION The sample spectrum must match with the spectrum of standard. Complies Appearance White to off-white powder Complies Assay (dry basis), w/% 97.0~102.0 99.12 N-[N-(3,3-Dimethylbutyl)-a- Aspartyl]-L-Phenylalanine, w/% 1.5 0.416 Water, w/% 5.0 4.52 Solubility Very soluble in Alcohol & Ethyl Acetate 1.26 % (w/w) at 25 C in water 4.75 % (w/w) at 60 C in water Complies Specific Rotation am (20,D)/[()dm2 kg-1] -40.0~-43.3 -42.476 Melting point 81 ~84 82.3 Related Substances, w/% 2.0 0.464 Ignited Residue, w/% 0.2 0.07 Residual Solvents Negative Complies pH (5g/L Solution) 5.0~7.0 5.47 Lead (Pb), ppm 1 Complies Total aerobic bacteria 250 cfu/g Complies Coliform 10 mpn/g Complies Fungi 100 cfu/g Complies Shigella Negative Complies Salmonella Negative Complies Staphylococcus aureus Negative Complies Storage Conditions: Preserve in well-closed containers, store in a dry place, and avoid exposure to excessive heat. Shelf Life: 2 years while stored in original packing under above stated condition. Conclusion: The product complies with USP, GB 29944-2013 & (EU) No 231/2012.