Analysis Note
Assay (acidimetric, calc. on anhydrous substance): 99.0 - 101.0 %
Identity: passes test
Appearance of solution (5 %; ethanol 96 %): passes test
Melting range (lower value): ≥ 133 °C
Melting range (upper value): ≤ 135 °C
Heavy metals (as Pb): ≤ 0.0010 %
As (Arsenic): ≤ 0.0003 %
Cd (Cadmium): ≤ 0.001 %
Cu (Copper): ≤ 0.001 %
Hg (Mercury): ≤ 0.0001 %
Pb (Lead): ≤ 0.0002 %
Zn (Zinc): ≤ 0.001 %
Aldehydes (as Acetaldehyd): ≤ 0.15 %
Acetone: ≤ 5000 ppm
Other residual solvents (ICH Q3C): excluded by the manufacturing process
Thermal stability (105 °C): No coloration
Loss on drying: ≤ 0.5 %
Water: ≤ 0.5 %
Sulfated ash: ≤ 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 (*).
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
Corresponds to Ph Eur, BP, NF, FCC, E 200
法律信息
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany