High-Purity Dirithromycin Active Pharmaceutical Ingredient for Global Pharmaceutical Manufacturers
Dirithromycin is a semi-synthetic macrolide antibiotic API widely used in oral anti-infective formulations for respiratory tract infections, skin infections, and community-acquired bacterial diseases. As a prodrug of erythromycylamine, Dirithromycin offers improved tissue penetration and once-daily dosing advantages compared with traditional erythromycin products.
Our pharmaceutical-grade Dirithromycin API is manufactured under strict GMP quality systems to support regulated and semi-regulated market supply chains, including formulation development, dossier registration, and long-term commercial procurement.
| Item | Specification |
|---|---|
| Product Name | Dirithromycin |
| CAS Number | 62013-04-1 |
| Molecular Formula | C42H78N2O14 |
| Molecular Weight | 835.07 g/mol |
| API Category | Macrolide Antibiotic |
| Appearance | White to off-white powder |
| Grade | Pharmaceutical Grade |
| Standard | In-house / Customer Specification |
| Shelf Life | 24 Months |
| Packaging | 1kg / 5kg / 25kg Fiber Drum |
| Storage | Store in cool, dry, sealed conditions |
Applications
Dirithromycin API is commonly used in formulations for:
- Community-acquired pneumonia
- Acute bronchitis
- Pharyngitis and tonsillitis
- Skin and soft tissue infections
- Respiratory tract bacterial infections
The API demonstrates activity against susceptible gram-positive and selected gram-negative organisms including:
- Streptococcus pneumoniae
- Streptococcus pyogenes
- Haemophilus influenzae
- Moraxella catarrhalis
- Mycoplasma pneumoniae
We Know What You Focus On
1. Impurity Control
- Known impurity identification
- Related substances control
- Residual solvent compliance
- Heavy metals compliance
2. Stability During Transportation
Dirithromycin is sensitive to acidic and alkaline degradation conditions. Proper packaging and controlled logistics are important for maintaining assay stability during export transportation.
3. Particle Size Consistency
Particle size distribution can influence:
- Tablet compression
- Dissolution profile
- Blending uniformity
Customized milling specifications may be supported upon request.
4. Registration Support
Global pharmaceutical buyers increasingly prioritize:
- Regulatory responsiveness
- Documentation completeness
- Audit transparency
- Long-term supply reliability
Frequently Asked Questions (FAQ)
Is Dirithromycin API available with GMP documentation?
Yes. GMP-related documentation and supporting quality files can be provided depending on project requirements.
Can you support dossier registration projects?
Yes. Technical documentation support for registration projects is available for selected markets.
What is the typical assay specification?
Customized specifications are available based on customer pharmacopeial or internal requirements.
Can you support pilot-scale and commercial-scale orders?
Yes. We support laboratory, pilot, and large commercial volumes.
Do you offer long-term supply agreements?
Yes. Annual contracts and scheduled supply programs are available for stable procurement planning.
Request a Technical Datasheet & Quotation
Looking for a reliable Dirithromycin API manufacturer with stable quality, regulatory support, and global export experience?
Contact us today for:
- Latest COA
- Technical datasheet
- Sample availability
- Commercial quotation
- Regulatory support package
- Lead time confirmation
