| Assay (HPLC, butylated hydroxyanisole) |
≥ 98.5 % |
| Assay (HPLC, 2-tert-butyl-4-methoxyphenol) |
≥ 90.0 % |
| Assay (HPLC, 3-tert-butyl-4-methoxyphenol) |
≤ 10.0 % |
| Identity (TLC) |
passes test |
| Identity (coloring 1) |
passes test |
| Identity (coloring 2) |
passes test |
| Identity (HPLC) |
passes test |
| Identity (IR-spectrum) |
passes test |
| Appearance |
White, yellowish or slightly pinkish crystalline powder. |
| Appearance of solution (100 g/l, ethanol 96 %) |
Clear and not more intensely colored than intensity 5 of the range of reference solutions of the most appropriate coloracc. to Ph. Eur. |
| Melting range |
48 - 63 °C |
| Absorption maximum λ 1 (Ethanol) |
289 - 292 nm |
| Absorption maximum λ 2 (Ethanol) |
227 - 230 nm |
| Spec. Absorptivity A 1%/1cm (λ1max; 0.02 g/l; ethanol) |
190 - 210 |
| Spec. Absorptivity A 1%/1cm (λ2max; 0.02 g/l; ethanol) |
326 - 345 |
| Heavy metals (as Pb) |
≤ 10 ppm |
| As (Arsenic) |
≤ 3 ppm |
| Hg (Mercury) |
≤ 1 ppm |
| Pb (Lead) |
≤ 2 ppm |
| Related substances (DC) (3-tert-Butyl-4-methoxyphenol) |
≤ 10 % |
| Related substances (DC) (Hydroquinone) |
≤ 0.2 % |
| Related substances (DC) (any other impurity) |
≤ 0.5 % |
| Residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Sulfated ash (600 °C) |
≤ 0.01 % |
| Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). |
|
| Corresponds to Ph. Eur., NF, E 320. Conforms to the purity criteria on food additives according to current European Commission Regulation. |
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