BENZYL ALCOHOL EMPROVE PH EUR,BP,NF

ürün Kodu : 100981.2500

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Specifications
Assay (GC) 98.0 - 100.5 %
Identity (IR) conforms
Appearance of solution (nephelometric) conforms
Clarity of solution conforms
Color 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

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