Spiramycin

SKU : AIM009
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CAS number

8025-81-8

molecular formula

C43H74N2O14

standard

EP6

Package

25kg/drum
ITEMS LIMIT
Appearance A white or slightly yellowish powder
Identification
A. UV Spectrum The specific absorbance at the maximum (232nm)
is about 340.
B. TLC Corresponds to reference solution.
C. Color Reaction Brown colour
pH 8.5-10.5
Specific optical rotation -80°- -85°(dried substance)
Composition (HPLC)
SpiramycinⅠ ≥80.0 %
SpiramycinⅡ ≤5.0 %
SpiramycinⅢ ≤10.0 %
Total Spiramycins ≥90.0 %
Related substances (HPLC)
Impurity A (neospiramycin I) ≤2.0 %
Impurity B (spiramycin IV) ≤2.0 %
Impurity C (17-methylenespiramycin I) ≤2.0 %
Impurity E (DSPM) ≤2.0 %
Impurity G (neospiramycin II) ≤2.0 %
Impurity H (neospiramycin III) ≤2.0 %
Impurity D (spiramycin V) ≤2.0 %
Impurity F (spiramycin dimer) ≤2.0 %
Any other impurity ≤2.0 %
Total impurities ≤10.0 %
Heavy metals ≤20ppm
Loss on drying ≤3.5 %
Sulphated ash ≤0.1 %
Assays (wet substance) No limits (IU/mg)
Assays (dried substance) ≥4100 IU/mg
Residual solvents
Dichloromethane ≤100 ppm
Methylisobutylketone ≤ 1000 ppm

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