Assay (calc. a.a.s): 99.0-101.0% Identity according to Pharmacopoeias: (A Ph. Eur / USP): passes test (B Ph. Eur / USP): passes test (C Ph. Eur / USP): passes test (D Ph. Eur): passes test Density 25/25: ≥ 1.249 Density 20/20: 1.258 - 1.268 Refractive Index n 20/D: 1.470-1.475 Specific gravity at 25°C: ≥1.249
Maximum limit of impurities Appearance of solution Appearance Transparent < formazin 50: passes test Appearance Colourless: passes test Acidity or alkalinity: < 0,2 ml NaOH 0,1M Residue on ignition (as SO4): 0.01 % Sugars: passes test Chloride (Cl): 0.0010% Sulfate (SO4): 0.002% Color: passes test Halogenated compounds Ph. Eur (as Cl): 0.0035% Chlorinated compounds USP (Cl): 0.003% Residual solvents (Ph.Eur/USP): passes test Aldehydes (as CH2O): 0.0010% Total impurities Tr > Tr glycerine: 0.5% Impurity A (Diethyleneglycol): 0.1% Individual Tr < Tr glycerine: 0.1% Impurity A and related substances (C.G.) Diethyleneglycol and ethyleneglycol impurities (CG) Diethyleneglycol: 0.1% Ethyleneglycol: 0.1% Esters Ph. Eur.: passes test Fatty Acids and Esters (USP): < 1 ml NaOH 0,1M Water (H2O): 2.0 % DOES NOT COME FROM ANIMAL ORIGIN.