Quick Facts
| CAS Number | 8025-81-8 |
|---|---|
| Molecular Formula | C43H74N2O14 (Spiramycin I, major component) |
| Molecular Weight | 843.05 (Spiramycin I) |
| Pharmacopoeia | EP/CEP |
| Packaging | 25 KG/DRUM |
EP/BP Standard
GMP Certified
Product Overview
Spiramycin Base (Pharma Grade) is a 16-membered macrolide antibiotic produced by Streptomyces ambofaciens. It is widely used in human medicine for its excellent tissue penetration and intracellular concentration, particularly in the treatment of toxoplasmosis during pregnancy.
Spiramycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. It achieves high tissue concentrations, especially in the respiratory tract, and concentrates in macrophages. It is the first-line treatment for toxoplasmosis in pregnancy due to its safety profile and ability to achieve high placental concentrations.
Quality Specifications
| Purity | As per EP monograph |
|---|---|
| Residual Solvents | Compliant with ICH Q3C |
| Heavy Metals | Compliant with pharmacopoeia limits |
| GMP Status | Manufactured under GMP conditions |
Pharmaceutical Applications
- Toxoplasmosis in pregnancy: First-line agent for prevention of congenital transmission
- Respiratory tract infections: Community-acquired pneumonia and acute bronchitis
- Periodontal infections: Oropharyngeal and dental infections
- Cryptosporidiosis: Treatment in immunocompromised patients