Especificações
Assay (HPLC) 97.0 - 102.0 %
Identity (IR-spectrum) conforms
Identity (UV-spectrum (USP)) conforms
Spec. rotation [a²0/D (8 g/l; (aldehyde-free alcohol 96 %) +105 - +112 °
Spec. rotation [a²5/D (5 g/l; ethanol) +105 - +112 °
As (Arsenic) = 3 ppm
Cu (Copper) = 25 ppm
Pb (Lead) = 10 ppm
Zn (Zinc) = 25 ppm
Acetone (HS-GC) = 5000 ppm
Hexane (HS-GC) = 290 ppm
Methanol (HS-GC) = 3000 ppm
Methylformate (HS-GC) = 1000 ppm
Pyridine (HS-GC) = 200 ppm
Other residual solvents (ICH Q3C) excluded by production process
Related substances (HPLC) (7,8-didehydrocholesterol) = 0.10 %
Related substances (HPLC) (trans-cholecalciferol) = 0.1 %
largest unspecified impurity = 0.10 %
Sum of all impurities = 1.0 %
Residues of metal catalysts or metal reagents acc.to EMEA/CHMP/SWP/4446/2000
are not likely to be present.
Corresponds to Ph Eur, BP, USP