- E-mail : info@cixmechpharma.com
Spiramycin is a macrolide antibiotic and antiparasitic. It is used to treat toxoplasmosis and various other infections of soft tissues.
Specification:
|
Test Item |
Analysis Specification |
Result |
|
Description |
A slightly yellowish or white power |
A slightly yellowish power |
|
Solubility |
Slightly soluble I water, freely soluble in acetone in ethanol(96%)and in methanol |
Conform |
|
pH |
8.5~10.5 |
10.0 |
|
Specific optical rotation |
-85°~ -80° |
-82° |
|
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 other impurity ≤2.0%
Total impurities ≤10.0% |
0.1% 1.0% 1.2% Not detected 1.6% 0.1% Not detected 0.12,0.19% 0.26,0.37% 4.5% |
|
Loss on drying |
≤3.5% |
0.9% |
|
Sulphated ash |
Not more than 0.1% |
0.06% |
|
Heavy metals |
≤20ppm |
<20ppm |
|
Butyl acetate |
≤5000ppm |
30ppm |
|
Assay |
Not less than 4100iu/mg calculated with reference to the substances |
4892iu/mg |
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
