翻译：新橙皮苷二氢查尔酮Neohesperidin-Dihydrochalcone
Neohesperidin-Dihydrochalcone(Ph Eur monograph 1547)
C28H36O15 613 20702-77-6
Ph Eur
DEFINITION
1-oxy]-2,6- dihydroxyphenyl]-3-(3-hydroxy-4-methoxyphenyl)propan-1-one.
Content
96.0 per cent to 101.0 per cent (anhydrous substance).
CHARACTERS
Appearance
White or yellowish-white powder.
Solubility
Practically insoluble in water, freely soluble in dimethyl sulphoxide, soluble in methanol, practically insoluble in methylene chloride.
IDENTIFICATION
A. Infrared absorption spectrophotometry (2.2.24).
Comparison neohesperidin-dihydrochalcone CRS.
B. Examine the chromatograms obtained in the assay.
Results The principal peak in the chromatogram obtained with test solution (b) is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution (a).
TESTS
Appearance of solution
The solution is clear (2.2.1) and not more intensely coloured than reference solution Y4 (2.2.2, Method II).
Dissolve 0.25 g in methanol R and dilute to 25 ml with the same solvent.
Related substances
Liquid chromatography (2.2.29).
Test solution (a) Dissolve 0.10 g of the substance to be examined in dimethyl sulphoxide R and dilute to 50.0 ml with the same solvent.
Test solution (b) Dilute 10.0 ml of test solution (a) to 20.0 ml with dimethyl sulphoxide R.
Reference solution (a) Dissolve 50.0 mg of neohesperidin-dihydrochalcone CRS indimethyl sulphoxide R and dilute to 50.0 ml with the same solvent.
Reference solution (b) Dissolve 4.0 mg of neohesperidin-dihydrochalcone impurity B CRS in dimethyl sulphoxide R and dilute to 100.0 ml with the same solvent.
Reference solution (c) Dilute 1.0 ml of test solution (a) to 100.0 ml with dimethyl sulphoxide R.
Reference solution (d) In order to prepare in situ impurity F and impurity G, suspend 0.10 g of the substance to be examined in 10.0 ml of a 100 g/l solution ofsulphuric acid R. Heat the sample for 5 min on a water-bath. Dilute immediately 1.0 ml of the resulting solution to 50.0 ml with dimethyl sulphoxide R.
Column:
—size: l = 0.15 m,
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