Form

Powder

Appearance

Whiteoralmostwhite,crystallinepowder

Source

Fusidiumcoccineum

ImpurityProfile

ImpurityA|ent-(24SR,17Z)-16a-(acetoxy)-3b,11b,24,25-tetrahydroxy-4b,8,14-trimethyl-18-nor-5b,10a-cholest-17(20)-en-21-oicacid(24,25-dihydroxyfusidicacid)||||ImpurityC|ent-(17Z)-3b,11b-dihydroxy-17-[(6S)-6-(1-Hydroxy-1-methylethyl)-2-oxodihydro-2H-pyran-3(4H)-ylidene]-4b,8,14-trimethyl-18-nor-5b,10a-androstan-16a-ylacetate((24R)-24,25-dihydroxyfusidicacid21,24-lactone)||||ImpurityD|ent-(17Z)-3b,11b-dihydroxy-17-[(6R)-6-(1-hydroxy-1-methylethyl)-2-oxodihydro-2H-pyran-3(4H)-ylidene]-4b,8,14-trimethyl-18-nor-5b,10a-androstan-16a-ylacetate((24S)-24,25-dihydroxyfusidicacid21,24-lactone||||ImpurityE|ent-(17Z)-16a-(acetyloxy)-3b,11b,27-trihydroxy-4b,8,14-trimethyl-18-nor-5b,10a-cholesta-17(20),24-dien-21-oicacid(27-hydroxyfusidicacid)||||ImpurityF|ent-(17Z)-16a-(acetyloxy)-3b,11b,27-trihydroxy-4b,8,14-trimethyl-18-nor-5b,10a-cholesta-17(20),24-dien-21-oicacid(27-hydroxyfusidicacid)||||ImpurityK|ent-(17Z)-3b,11b,16a-trihydroxy-4b,8,14-trimethyl-18-nor-5b,10a-cholesta-17(20),24-dien-21,16-lactone(16-deacetylfusidicacid21,16-lactone)||||ImpurityUN1|FusidateSodium||||

WaterContent(KarlFisher)

1.4%-2.0%

Assay

(Anhydrous)97.5%-101.0%