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Brand:aa
Product detail:
Product: Spiramycin
CAS NO.:8025-81-8
Appearance:A White power
Use: Macrolides antibiotics
Purity:99%
MOQ:1kg
Packing:25kg/drum
Delivery:3-5working days after receipt of the payment
Test Item | Analysis Specification | Result |
Description | A slightly yellowish or white power | A slightly yellowish power |
Identification | UV spectrum according to Ph.Eur.7.0 TLC according to Ph.Eur.7.0 Colorimetric test according to Ph.Eur.7.0
|
Conform
|
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% Conforms |
Loss on drying | ≤3.5% | 0.9% |
Sulphated ash | Not more than 0.1% | 0.06% |
Heavy metals | ≤20ppm | <20ppm |
Butyl acetate | ≤5000ppm | 30ppm |
Composition | SpiramycinⅠ:not less than80.0% SpiramycinⅡ: not more than5.0% Spiramycin Ⅲ: not more than10.0% Total SpiramycinⅠ,Ⅱ,Ⅲ: not less than90.0% | 95.8% 0.2% 0.3% 96.3% |
Assay | Not less than 4100iu/mg calculated with reference to the substances | 4892iu/mg |
Conclusion | The above certificate of analysis is in compliance with Ph.Eur.7.0 | |
