Form

Powder

Appearance

White or almost white, crystalline powder

Source

Fusidium coccineum

Impurity Profile

Impurity A| ent-(24SR,17Z)-16a-(acetoxy)-3b,11b,24,25-tetrahydroxy-4b,8,14-trimethyl-18-nor-5b,10a-cholest-17(20)-en-21-oic acid (24,25-dihydroxyfusidic acid)|||| Impurity C| 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-yl acetate ((24R)-24,25-dihydroxyfusidic acid 21,24-lactone)|||| Impurity D| 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-yl acetate ((24S)-24,25-dihydroxyfusidic acid 21,24-lactone|||| Impurity E| ent-(17Z) -16a-(acetyloxy)-3b,11b,27-trihydroxy-4b,8,14-trimethyl-18-nor-5b,10a-cholesta-17(20),24-dien-21-oic acid (27-hydroxyfusidic acid)|||| Impurity F| ent-(17Z) -16a-(acetyloxy)-3b,11b,27-trihydroxy-4b,8,14-trimethyl-18-nor-5b,10a-cholesta-17(20),24-dien-21-oic acid (27-hydroxyfusidic acid)|||| Impurity K| ent-(17Z) -3b,11b,16a-trihydroxy-4b,8,14-trimethyl-18-nor-5b,10a-cholesta-17(20),24-dien-21,16-lactone(16-deacetylfusidic acid 21,16-lactone)|||| Impurity UN1| Fusidate Sodium||||

Water Content (Karl Fisher)

1.4% - 2.0%

Assay

(Anhydrous) 97.5% - 101.0%