药典右泛参比溶液用丙醇测试稀释至药大生药学0761e.pdfVIP

EUROPEANPHARMACOPOEIA7.0Dexpanthenol

Referencesolution(c).Dilute1.0mLofthetestsolutionto01/2008:0761

50mLwith2-propanolR.

Column:DEXPANTHENOL

—size:l=0.25m,Ø=4.6mm;

Dexpanthenolum

—stationaryphase:amylosederivativeofsilicagelfor

chromatographyR.

Mobilephase:diethylamineR,2-propanolR,hexaneR

(3:20:980V/V/V).

Flowrate:1mL/min.

CHNOM205.3

9194r

Detection:spectrophotometerat254nm.[81-13-0]

Injection:10μL.

DEFINITION

Undertheseconditionsthepeakduetothe(S)-isomerappearsDexpanthenolcontainsnotlessthan98.0percent

first.

andnotmorethantheequivalentof101.0percentof

Systemsuitability:(2R)-2,4-dihydroxy-N-(3-hydroxypropyl)-3,3-dimethylbutanamide,

—resolution:minimum1.5betweenthepeaksduetothecalculatedwithreferencetotheanhydroussubstance.

(R)-enantiomer(impurityB)andthe(S)-enantiomerintheCHARACTERS

chromatogramobtainedwithreferencesolution(b);