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StreptomycesAmbofaciens

ElementalAnalysis

Composition:
SpiramycinI:≥80.0%
SpiramycinII:≤5.0%
SpiramycinIII:≤10.0%
SumofSpiramycinI,II,III:≥90.0%

ImpurityProfile

SpiramycinI||24916-50-5|C₄₃H₇₄N₂O₁₄|834.1|SpriamycinII||24916-51-6|C₄₅H₇₆N₂O₁₅|885.1|SpiramycinIII||24916-52-7|C₄₆H₇₈N₂O₁₅|899.1|ImpurityA|(4R,5S,6S,7R,9R,10R,11E,13E,16R)-6-[[3,6-dideoxy-3-(dimethylamino)-d-glucopyranosyl]oxy]-4-hydroxy-5-methoxy-9,16-dimethyl-7-(2-oxoethyl)-10-[[2,3,4,6-tetradeoxy-4-(dimethylamino)-d-erythro-hexopyranosyl]oxy]oxacyclohexadeca-11,13-dien-2-one(neospiramycinI)|70253-62-2|C₃₆H₆₂N₂O₁₁|698.88|ImpurityB|(4R,5S,6S,7R,9R,10R,11E,13E,16R)-6-[[3,6-dideoxy-4-O-(2,6-dideoxy-3-C-methyl-l-ribo-hexopyranosyl)-3-(dimethylamino)-d-glucopyranosyl]oxy]-4-hydroxy-7-(2-hydroxyethyl)-5-methoxy-9,16-dimethyl-10-[[2,3,4,6-tetradeoxy-4-(dimethylamino)-d-erythro-hexopyranosyl]oxy]oxacyclohexadeca-11,13-dien-2-one(spiramycinIV)||||ImpurityC|(4R,5S,6S,7S,9R,10R,11E,13E,16R)-6-[[3,6-dideoxy-4-O-(2,6-dideoxy-3-C-methyl-汐-l-ribo-hexopyranosyl)-3-(dimethylamino)-d-glucopyranosyl]oxy]-7-(1-formylethenyl)-4-hydroxy-5-methoxy-9,16-dimethyl-10-[[2,3,4,6-tetradeoxy-4-(dimethylamino)-d-erythro-hexopyranosyl]oxy]oxacyclohexadeca-11,13-dien-2-one(17-methylenespiramycinI)||||ImpurityD|(4R,5S,6S,7R,9R,10R,11E,13E,16R)-6-[[3,6-dideoxy-4-O-(2,6-dideoxy-3-C-methyl-汐-l-ribo-hexopyranosyl)-3-(dimethylamino)-d-glucopyranosyl]oxy]-10-[(2,6-dideoxy-3-C-methyl-汐-l-ribo-hexopyranosyl)oxy]-4-hydroxy-5-methoxy-9,16-dimethyl-7-(2-oxoethyl)oxacyclohexadeca-11,13-dien-2-one(spiramycinV)||||ImpurityE|(4R,5S,6S,7S,9R,10R,11E,13E,16R)-6-[[3,6-dideoxy-4-O-(2,6-dideoxy-3-C-methyl-汐-l-ribo-hexopyranosyl)-3-(dimethylamino)-d-glucopyranosyl]oxy]-7-ethyl-4-hydroxy-5-methoxy-9,16-dimethyl-10-[[2,3,4,6-tetradeoxy-4-(dimethylamino)-d-erythro-hexopyranosyl]oxy]oxacyclohexadeca-11,13-dien-2-one(18-deoxy-18-dihydrospiramycinIorDSPM)||||ImpurityF|spiramycindimer||||ImpurityG|(4R,5S,6S,7R,9R,10R,11E,13E,16R)-6-[[3,6-dideoxy-3-(dimethylamino)-d-glucopyranosyl]oxy]-5-methoxy-9,16-dimethyl-2-oxo-7-(2-oxoethyl)-10-[[2,3,4,6-tetradeoxy-4-(dimethylamino)-d-erythro-hexopyranosyl]oxy]oxacyclohexadeca-11,13-dien-4-ylacetate(neospiramycinII)||||ImpurityH|(4R,5S,6S,7R,9R,10R,11E,13E,16R)-6-[[3,6-dideoxy-3-(dimethylamino)-d-glucopyranosyl]oxy]-5-methoxy-9,16-dimethyl-2-oxo-7-(2-oxoethyl)-10-[[2,3,4,6-tetradeoxy-4-(dimethylamino)-d-erythro-hexopyranosyl]oxy]oxacyclohexadeca-11,13-dien-4-ylpropanoatate(neospiramycinIII)|4617-99-6|C₃₉H₆₆N₂O₁₂|754.95|

pH

8.5-10.5

OpticalRotation

-80.0°to-85.0°

Assay

(OnDriedBasis):≥4100IU/mg

LossonDrying

≤3.5%