مشخصات فنی محصول | |
---|---|
Assay (GC) | 98.0 - 100.5 % |
Identity (IR) | conforms |
Appearance of solution (nephelometric) | conforms |
Clarity of solution | conforms |
Colour of solution | conforms |
Acidity | conforms |
Refractive index (n 20/D) | 1.538 - 1.541 |
Density (d 20 °C/20 °C) | 1.043 - 1.049 |
Peroxide value | ≤ 5.0 |
Related substances (GC) (Benzaldehyde (Impurity A)) | ≤ 0.15 % |
Related substances (GC) (Cyclohexylmethanol (Impurity B)) | ≤ 0.10 % |
Related substances (GC) (Sum of peaks with a relative retention less than that of benzyl alcohol) | ≤ 0.04 % |
Related substances (GC) (Sum of peaks with a relative retention greater than that of benzyl alcohol) | ≤ 0.3 % |
Related substances (GC) (disregard limit) | ≤ 0.0001 % |
Benzene (GC) | ≤ 0.0002 % |
Chlorobenzene (GC) | ≤ 0.01 % |
Toluene (GC) | ≤ 0.01 % |
Other residual solvents (ICH Q3C) | excluded by manufacturing process |
Evaporation residue | ≤ 0.050 % |
Water | ≤ 0.10 % |
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present. Conforms to Ph Eur, BP, JP, NF |