مشخصات فنی محصول | |
---|---|
Assay (spectrophotometrically; calc. on dried substance) | 98.0 - 102.0 % |
Appearance | yellow to orange yellowish powder |
Identity (TLC) | conforms |
Identity (Fluorescence test) | conforms |
Identity (IR-spectrum) | conforms |
Absorbance maxima | at about 223 nm, 267 nm, 373 nm and 444 nm |
Absorption ratio (A 373 nm / A 267 nm) | 0.31 - 0.33 |
Absorption ratio (A 444 nm / A 267 nm) | 0.36 - 0.39 |
Spec. rotation [α²0/D (5 g/l, sodium hydroxide (0.05 mol/l), calc. on dried substance, Ph. Eur.) | -135 - -115 ° |
Spec. rotation [α²0/D (5 g/l, dilute sodium hydroxide and ethanol, calc. on dried substance, JP) | -142 - -128 ° |
Spec. rotation [α²5/D (5 g/l, sodium hydroxide (0.05 mol/l), calc. on dried substance, USP) | -135 - -115 ° |
Primary aromatic amines (as Aniline) | ≤ 100 ppm |
Heavy metals (as Pb) | ≤ 40 ppm |
As (Arsenic) | ≤ 3 ppm |
Cd (Cadmium) | ≤ 1 ppm |
Hg (Mercury) | ≤ 1 ppm |
Pb (Lead) | ≤ 10 ppm |
Lumiflavin (USP) | passes test |
Residual solvents (Ph.Eur./USP/ICH) class 2 (Methanol) | ≤ 3000 ppm |
Residual solvents (Ph.Eur./USP/ICH) class 3 (3-Methyl-1-butanol) | ≤ 5000 ppm |
Other residual solvents (Ph.Eur./USP/ICH) | excluded by production process |
Related substances (HPLC) (Impurity A (Lumiflavin)) | ≤ 0.025 % |
Related substances (HPLC) (Impurity B) | ≤ 0.20 % |
Related substances (HPLC) (Impurity C) | ≤ 0.20 % |
Related substances (HPLC) (Impurity D) | ≤ 0.20 % |
Related substances (HPLC) (Largest unspecified impurity) | ≤ 0.10 % |
Related substances (HPLC) (Sum of all impurities) | ≤ 0.5 % |
Sulfated ash (600 °C) | ≤ 0.1 % |
Loss on Drying (105°C) | ≤ 1.5 % |
Corresponds to Ph Eur, BP, JP, USP, E 101 Conforms to the purity criteria on food additives according to the EuropeanCommission directive 2008/128/EC. |