翻译：新橙皮苷二氢查尔酮Neohesperidin-Dihydrochalcone

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Neohesperidin-Dihydrochalcone
(Ph Eur monograph 1547)

C28H36O15   613   20702-77-6

Ph Eur
  
DEFINITION
  
1-[4-[[2-O-(6-Deoxy-a-L-mannopyranosyl)-b-D-glucopyranosyl]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 in  dimethyl 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 of  sulphuric 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,