2850 dexpanthenol专着2851-右甲醇制备.pdfVIP

2850Dexpanthenol/OfficialMonographsUSP35

Acceptancecriteria:98.0%–102.0%ontheanhydrousbasis

DexpanthenolIMPURITIES

•RESIDUEONIGNITION〈281〉:NMT0.1%

•LIMITOFAMINOPROPANOL

Sample:5gofDexpanthenol

Blank:10mLofwater

Titrimetricsystem

C9H19NO4205.25(SeeTitrimetry〈541〉.)

Butanamide,2,4-dihydroxy-N-(3-hydroxypropyl)-3,3-dimeth-Mode:Directtitration

yl-,(R)-;Titrant:0.1NsulfuricacidVS

D-(+)-2,4-Dihydroxy-N-(3-hydroxypropyl)-3,3-dimethyl-Endpointdetection:Visual

butyramide[81-13-0].Analysis:DissolvetheSamplein10mLofwater,andadd

bromothymolblueTS.TitratewiththeTitranttoayellow

DEFINITIONendpoint.PerformtheBlankdetermination.

DexpanthenolcontainsNLT98.0%andNMT102.0%of