Custom Premix Selecting "Custom Premix" option means that all of the beads you have chosen will be premixed in manufacturing before the kit is sent to you.
clear and not more intense in colour than colour reference solution BY₄ (Ph Eur)
Melting range (lower value)
≥ 107 °C
Melting range (upper value)
≤ 117 °C
Spec. rotation [α²0/D (100 g/l, Methanol,
calc. on dried basis)
+21 - +24 °
Spec. rotation [α! 20/D (50 g/l, Methanol)
+21 - +24 °
Spec. rotation [α²5/D (100 g/l, Methanol,
calc. on dried basis)
+21 - +24 °
Spec. rotation [α! 25/D (100 g/l, Methanol)
+21 - +24 °
As (Arsenic)
≤ 3 ppm
Cu (Copper)
≤ 25 ppm
Hg (Mercury)
≤ 1 ppm
Ni (Nickel)*
≤ 2 ppm
Pb (Lead)
≤ 2 ppm
Zn (Zinc)
≤ 25 ppm
Ethyl acetate (HS-GC)
≤ 5000 ppm
Methylisobutylketone (HS-GC)
≤ 4500 ppm
Other residual solvents (ICH Q3C)
excluded by production process
Sulfated ash (600 °C)
≤ 0.1 %
Loss on drying (5 h, 60 °C, Vacuum)
≤ 1.0 %
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, BP, NF, FCC, E 304 Conforms to the purity criteria on food additives according to the current European Commission Regulation.
