Synonyms Foromacidin; Leucomycin; Provamycin; Rovamycin;
CAS Number: 8025-81-8
Molecular Formula: C43H74N2O14
Molecular Weight: 843.06
Characteristic: A white or slightly yellowish powder, Slightly odorless, Slightly hygroscopic, slightly soluble in water, freely soluble in acetone, in alcohol and in methanol.
Function and Use:
It can be used for the infections in ears, nasus, larynx and respiratory tract system caused by gram-positive bacterium and some gram-negative bacterium such as acute bronchitic, acute bout of acute bronchitis, pneumonia, scarlet fever, tonsillitis, tympanitis, periodontitis and acute nososinusitis. It also shows suitable to non-gonococcal urethritis. It possesses strong internal antibacterial function and Post-Antibiotic Effect (PAE). It’s able to improve the phagocytosis of phagocyte and is widely distributed in body. The concentration in histiocyte is higher than erythromycin and is less adverse reaction as well.
Certificate Of Analysis: EP6.1 Edition
|
Item |
Standard |
Test Result |
|
Characteristics |
A slightly yellowish or white powder |
Conform |
|
Solubility |
Slightly soluble in water, freely soluble in acetone in ethanol(96%) and in methanol |
Conform |
|
Identification |
UV spectrum according to EP6.1 |
Conform |
|
TLC according to EP6.1 |
Conform |
|
|
Colorimetric test according to EP6.1 |
Conform |
|
|
PH |
8.5~10.5 |
9.7 |
|
Specific optical rotation |
-85°~-80° |
-81° |
|
Loss on drying |
≤3.5% |
1.90% |
|
Heavy Metals |
≤20ppm |
Conform |
|
Related Substances |
Impurity A ≤2.0% |
1.10% |
|
Impurity B ≤2.0% |
1.30% |
|
|
Impurity C ≤2.0% |
Conform |
|
|
Impurity D ≤2.0% |
Conform |
|
|
Impurity E ≤2.0% |
Conform |
|
|
Impurity F ≤2.0% |
1.40% |
|
|
Impurity G ≤2.0% |
Conform |
|
|
Impurity H ≤2.0% |
Conform |
|
|
Any other impurity ≤2.0% |
0.21%,0.27%,0.24%,0.16%, |
|
|
0.29%,0.54%,0.42%,0.11% |
||
|
0.33%,0.14% |
||
|
Total impurities ≤10.0% |
5.00% |
|
|
Sulphated Ash |
≤0.1% |
0.07% |
|
Butyl acetate |
≤5000ppm |
200ppm |
|
Composition |
Spiramycin I ≥80.0% |
94.10% |
|
Spiramycin II≥5.0% |
0.10% |
|
|
Spiramycin III≥10.0% |
0.60% |
|
|
Total Spiramycin I,II,III≥90.0% |
94.80% |
|
|
Assay |
≥4100iu/mg calculated with reference to the anhydrous substances |
4780iu/mg |