Listing ID #4906111
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Test Item | Specification | Test Method / Reference |
---|---|---|
Appearance | White Powder | Visual |
Odor/Taste | Conforms to Quality Standards | Internal Method |
Identification | Meets Requirements | Current FCC / USP/NF / JECFA / EP |
Assay (on dry basis) | 98.0% to 102% | Current FCC / USP/NF / JECFA / EP |
Loss on Drying | ≤ 4.5% | Current FCC / USP/NF / JECFA / EP |
Residue on Ignition / Sulphated Ash | < 0.2% | Current FCC / USP/NF / JECFA / EP |
Optical (Specific) Rotation | +14.5° and +16.5° | Current FCC / USP/NF / JECFA / EP |
Conductivity | ≤ 30 μScm-1 | EP |
Transmittance | ≥ 95% | Current USP/NF /JECFA |
Extraneous Matter | Free from material foreign to product | Free from visual evidence |
pH (0.8% Solution) | 4.5 ~6.0 | Current FCC/JECFA |
Heavy Metal (as Pb) | ≤ 10 ppm | Current USP/NF / JP / EP |
Lead | < 1 ppm | Current FCC / JECFA |
Arsenic | < 3 ppm | Current FCC |
Residual Solvents | Meets Requirements | Current USP/NF |
5-benzyl-3,6-dioxo-2 Piperazineacetic Acid (DKP) | ≤ 1.5% | Current USP / NF / FCC / JECFA Current |
Other Related Substances | ≤ 2.0% USP/NF; ≤ 1.5% EP | USP/NF |
L-phenylalanine | ≤ 0.5% | Current EP |
Solubility | Completely Dissolves | Internal Method |
Particle Size | NMT 5% on 100 mesh | Internal Method |
Bulk Density | 0.3 +/- 0.1 g/mL | Internal Method |
Total Aerobic Plate Count | ≤ 250 CFU/g | GB |
Yeast and Mold Count | ≤ 100 CFU/g | GB |
Coliforms | ≤ 3.0 MPN/g | GB |
Escherichia Coli | Negative/g | GB |
Salmonella | Negative/25g | GB |