Form

Powder

Appearance

White or almost White Crystalline Powder

Source

Synthetic

Impurity Profile

Impurity A| (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-Ethenyl-5,8-dihydroxy-4,6,9,10-tetramethyl-octahydro-3a,9-propano-3aH-cyclopentacyclo-octen-1(4H)-one (Mutilin)|6040-37-5|C₂₀H₃₂O₃|320.5| Impurity B| 2-(Benzylsulphanyl)-N,N-diethylethanamine Hydrochloride||C₁₃H₂₁NS_{|223.38| Impurity C| 2,2'-(Disulphane-1,2-diyl)bis(N,N-diethylethanamine) Dihydrochloride||C12H30Cl2N2S2|336.12| Impurity E| (3aS,4R,6S,8R,9R,9aR,10R)-6-Ethenyl-4,6,9,10-tetramethyl-1,5-dioxodeca-hydro-3a,9-propano-3aH-cyclopentacyclo-octen-8-yl [[2-(Diethylamino)ethyl]sulph|||| Impurity G| (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-Ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxo-decahydro-3a,9-propano-3aH-cyclopentacyclo-octen-8-yl Hydroxyacetate (Pleuomutilin)|125-65-5|C22H34O5|378.50| Impurity J| (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-Ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxo-decahydro-3a,9-propano-3aH-cyclopentacyclo-octen-8-yl Acetate (Mutilin 14- acetate)|||| Impurity K| (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyl-8-hydroxy-4,6,9,10-tetramethyl-1-oxodecahydro-3a,9-propano-3aH-cyclopentacycloocten-5-yl acetate (mutilin 11-acetate)|||| Impurity L| (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxodecahydro-3a,9-propano-3aH-cyclopentacycloocten-8-yl [[(4-methylphenyl)sulfonyl]oxy]acetate (pleuromutilin 22-tosylate|||| Impurity M| (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyl-4,6,9,10-tetramethyl-1-oxodecahydro-3a,9-propano-3aH-cyclopentacycloocten-5,8-diyl diacetate (mutilin 11,14-diacetate)|||| Impurity N| (2E)-4-[2-[[(3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxodecahydro-3a,9-propano-3aH-cyclopentacycloocten-8-yl]oxy]-2-oxoethoxy]-4-oxobut-2-enoic acid (pleuromutilin 22-fumarate)|||| Impurity O| 2-(diethylamino)ethanethiol|13242-44-9|(CH3)2NCH2CH2SH﹞HCl|141.66| Impurity P| (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxodecahydro-3a,9-propano-3aH-cyclopentacycloocten-8-yl [(phenylsulfonyl)oxy]acetate|||| Impurity Q| (3aS,4R,5S,6S,8R,9R,10R)-6-ethenyl-2,5-dihydroxy-4,6,9,10-tetramethyl-2,3,4,5,6,7,8,9-octahydro-3a,9-propano-3aH-cyclopentacycloocten-8-yl [[2-(diethylamino)ethyl]sulfanyl]acetate (3,4-didehydro-2-hydroxytiamulin)|||| Impurity T| (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxodecahydro-3a,9-propano-3aH-cyclopentacycloocten-8-yl [[2-[[2-(diethylamino)ethyl]sulfanyl]ethyl]sulfanyl]acetate|||| Impurity R| N-benzyl-N,N-dibutylbutan-1-aminium|23616-79-7|C19H34ClN|311.933| Impurity S| (1RS,3aR,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyl-1-ethyl-1,5-dihydroxy-4,6,9,10,12,12-hexamethyldecahydro-3a,9-propano-3aH-cyclopentacycloocten-8-yl [[2-(diethylamino)ethyl]sulfanyl]acetate||||}

pH

3.1-4.1

Melting Point

143-149°C

Optical Rotation

+24.0 to +28.0°

Assay

(On Dried Basis): 98.0-102.0%

Loss on Drying

≤0.5%