SUNFLOWER OIL, REFINED Helianthi annui oleum raffinatum

Sunflower oil, refined
EUROPEAN PHARMACOPOEIA 7.0
(2034). It is therefore not necessary to identify these impurities
for demonstration of compliance. See also 5.10. Control of
impurities in substances for pharmaceutical use) : F, G.
01/2010:1371
SUNFLOWER OIL, REFINED
Helianthi annui oleum raffinatum
DEFINITION
Fatty oil obtained from the seeds of Helianthus annuus L. by
mechanical expression or by extraction. It is then refined. A
suitable antioxidant may be added.
A. [3-[2-(dimethylamino)ethyl]-2-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-1H-indol-5-yl]-N-methylmethanesulfonamide,
CHARACTERS
Appearance: clear, light yellow liquid.
Solubility : practically insoluble in water and in ethanol (96 per
cent), miscible with light petroleum (bp : 40-60 °C).
Relative density : about 0.921.
Refractive index : about 1.474.
IDENTIFICATION
Identification of fatty oils by thin-layer chromatography (2.3.2).
Results : the chromatogram obtained is similar to the
corresponding chromatogram shown in Figure 2.3.2.-1.
B. R1 = R2 = H : N-methyl[3-[2-(methylamino)ethyl]-1H-indol-5yl]methanesulfonamide,
C. R1 = CH2-OH, R2 = CH3 : [3-[2-(dimethylamino)ethyl]-1-(hydroxymethyl)-1H-indol-5-yl]-N-methylmethanesulfonamide,
D. N,N-dimethyl-2-[5-[(methylsulfamoyl)methyl]-1H-indol-3yl]ethanamine N-oxide,
TESTS
Acid value (2.5.1) : maximum 0.5, determined on 10.0 g.
Peroxide value (2.5.5, Method A) : maximum 10.0.
Unsaponifiable matter (2.5.7) : maximum 1.5 per cent,
determined on 5.0 g.
Alkaline impurities (2.4.19). It complies with the test.
Composition of fatty acids (2.4.22, Method A). Use the mixture
of calibrating substances in Table 2.4.22.-3.
Composition of the fatty-acid fraction of the oil:
— palmitic acid : 4.0 per cent to 9.0 per cent,
— stearic acid : 1.0 per cent to 7.0 per cent,
— oleic acid : 14.0 per cent to 40.0 per cent,
— linoleic acid : 48.0 per cent to 74.0 per cent.
Water (2.5.32): maximum 0.1 per cent, determined on 1.00 g.
STORAGE
In an airtight, well-filled container, protected from light.
LABELLING
The label states whether the oil is obtained by mechanical
expression or by extraction.
E. [3-(2-aminoethyl)-1H-indol-5-yl]-N-methylmethanesulfonamide,
01/2008:0248
SUXAMETHONIUM CHLORIDE
Suxamethonii chloridum
F. R = H : N-methyl(2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indol-6yl)methanesulfonamide,
G. R = CH3 : N-methyl(2-methyl-2,3,4,9-tetrahydro-1H-pyrido[3,4C14H30Cl2N2O4,2H2O
b]indol-6-yl)methanesulfonamide,
[6101-15-1]
Mr 397.3
DEFINITION
Suxamethonium chloride contains not less than 98.0 per
cent and not more than the equivalent of 102.0 per cent of
2,2′-[butanedioylbis(oxy)]bis(N,N,N-trimethylethanaminium)
dichloride, calculated with reference to the anhydrous
substance.
H. [3-[2-(dimethylamino)ethyl]-1-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-1H-indol-5-yl]-N-methylmethanesulfonamide.
3028
CHARACTERS
A white or almost white, crystalline powder, hygroscopic, freely
soluble in water, slightly soluble in alcohol.
It melts at about 160 °C, determined without previous drying.
See the information section on general monographs (cover pages)