产品编号:100981 产品英文名:Benzyl alcoholsuitable for use as excipient EMPROVE® exp Ph Eur,BP,JP,NF 产品中文名:苯甲醇 用途: 药用辅料,赋形剂
规格
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 %
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 Ph Eur, BP, JP, NF