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1 Kilogram |
Negotiable |
Spiramycin Spiramycin EP Spiramycin
EP
Spiramycin
Characteristics |
White or slightly yellowish powder ,solubility should meet the requirement |
Identification |
A UV test:conforms B TLC test:conforms C A brown color develops |
PH |
8.5-10.5 |
Specific optical rotation |
-85°to -80° |
Related substances |
Impurity A≤2.0% |
|
Impurity B≤2.0% |
|
Impurity D≤2.0% |
|
Impurity E≤2.0% |
|
Impurity F≤2.0% |
|
Impurity G≤2.0% |
|
Impurity H≤2.0% |
|
Any unspecified impurity≤1.5% |
|
Total impurities≤10.0% |
Loss on drying |
≤3.5% |
Heavy metals |
≤20ppm |
Sulphated ash |
≤0.1% |
Butyl acetate |
≤5000ppm |
Composition |
Spiramycin I≥80.0% |
|
Spiramycin ≤5.0% |
|
Spiramycin ≤10.0% |
|
Total Spiramycin I,II,I≥90% |
Assay |
≥4100IU/mg calculated with reference to the anhydrous substances |
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