| Assay (GC) |
≥ 99.0 % |
| Assay (HPLC) |
99.0 - 101.5 % |
| Identity (Identification 1 (JPE)) |
passes test |
| Identity (IR-spectrum) |
passes test |
| Identity (Identification 2 (JPE)) |
passes test |
| Identity (HPLC) |
passes test |
| Appearance |
White to yellowish crystalline powder. |
| Appearance of solution (100 g/l, methanol (Ph Eur)) |
Clear and not more intense in color than reference solutionY₅ or BY₅. |
| Appearance of solution (100 g/l, ethanol (95 )% (JPE)) |
Clear and colorless. |
| Solidification temperature |
69.2 - 70.0 °C |
| Melting point |
69.5 - 72.0 °C |
| Absorption maximum λmax. (ethanol abs.) |
277 - 279 nm |
| Spec. Absorptivity A 1%/1cm (λmax; 0.02 g/l; ethanol abs.) |
81 - 88 |
| Spec. Absorptivity A 1%/1cm (λ₂₇₈ nm; 0.05 g/l; ethanol (95 %)) |
82 - 88 |
| Heavy metals (as Pb) |
≤ 10 ppm |
| Sulphate (SO₄) |
≤ 150 ppm |
| As (Arsenic) |
≤ 3 ppm |
| Hg (Mercury) |
≤ 1 ppm |
| Pb (Lead) |
≤ 2 ppm |
| tert-butanol (GC) |
≤ 1000 ppm |
| Diisobutylene (GC) |
≤ 100 ppm |
| p-Cresol |
≤ 0.1 % |
| 2-Propanol (GC) |
≤ 2000 ppm |
| Related substances (TLC) |
≤ 0.5 % |
| Related substances (HPLC) (p-Cresol oder m-cresol) |
≤ 0.1 % |
| Related substances (HPLC) (3-tert-Butyl-4-hydroxyanisole) |
≤ 0.1 % |
| Related substances (HPLC) (3,5-Di-tert-butyl-4-hydroxybenzoic acid) |
≤ 0.1 % |
| Related substances (HPLC) (2-tert-Butyl-4-methylphenol or 2-tert-butyl-5-methylphenol) |
≤ 0.1 % |
| Related substances (HPLC) (3,5-Di-tert-butyl-4-hydroxy benzaldehyde) |
≤ 0.1 % |
| Related substances (HPLC) (4,6-Di-tert-butyl-m-cresol) |
≤ 0.1 % |
| Related substances (HPLC) (2,6-Di-tert-butyl-phenol) |
≤ 0.1 % |
| Related substances (HPLC) (Any unspecified impurity) |
≤ 0.1 % |
| Related substances (HPLC) (Sum of all impurities) |
≤ 0.7 % |
| Other residual solvents (ICH Q3C) |
passes test |
| Sulfated ash (600 °C) |
≤ 0.002 % |
| Water (according to Karl Fischer) |
≤ 0.2 % |
| 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., JPE, NF, E 321. Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
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