Basic Product Information
Tilmicosin Phosphate Generic is a cost-effective yet high-quality alternative to branded veterinary antibiotics, offering identical therapeutic benefits while maintaining strict quality standards. This generic API provides reliable treatment for respiratory infections in various animal species.
|
Parameter |
Specification |
|
Product Name |
Tilmicosin Phosphate Generic API |
|
CAS Number |
137330-13-3 |
|
Molecular Formula |
C₄₆H₈₀N₂O₁₃·H₃PO₄ |
|
Appearance |
White to light yellow crystalline powder |
|
Purity |
≥ 98.0% |
|
Heavy Metals |
≤ 20 ppm |
|
Residual Solvents |
Meets ICH Q3C Guidelines |
|
Microbial Limits |
Complies with EP/VP requirements |
Production & Processing
Manufacturing Process:
Our generic Tilmicosin Phosphate is produced using optimized synthesis routes that ensure both cost efficiency and quality consistency. The manufacturing process includes:
- Advanced Synthesis: Multi-step chemical synthesis under controlled conditions
- Purification Technology: Multi-stage crystallization and filtration processes
- Quality Control: Rigorous in-process testing at critical stages
- Drying Process: Low-temperature vacuum drying to preserve stability
Quality Systems:
Full compliance with GMP standards
Environmental controls throughout production
Automated process monitoring systems
Comprehensive documentation practices
Regular equipment calibration and validation
Facility Standards:
Dedicated generic API production lines
Climate-controlled manufacturing areas
Advanced dust control systems
Separate packaging and storage facilities
On-site quality control laboratories
Product Advantages & Selling Points
Quality Advantages:
Bioequivalent to branded reference products
Consistent batch-to-batch quality
Excellent solubility and bioavailability
Stable under various storage conditions
Cost Benefits:
Significant cost savings compared to branded alternatives
Competitive pricing without compromising quality
Bulk purchasing discounts available
Flexible payment terms for regular customers
Supply Chain Advantages:
Reliable and consistent supply
Multiple manufacturing batches monthly
Large inventory capacity
Efficient logistics and global shipping
Regulatory Compliance:
DMF available for regulatory submissions
Complete regulatory support documentation
GMP compliance certificates
Export licenses for global markets
Customer Support:
Technical assistance for formulation development
Stability data and regulatory guidance
Custom packaging options
Sample availability for testing and evaluation
Frequently Asked Questions (FAQ)
Q: Is generic Tilmicosin Phosphate as effective as the branded version?
A: Yes, our generic Tilmicosin Phosphate demonstrates bioequivalence to branded products and meets all pharmacopeial standards for purity, potency, and efficacy.
Q: What documentation accompanies each shipment?
A: Each batch includes Certificate of Analysis, Material Safety Data Sheet, Certificate of GMP Compliance, and all necessary export documentation.
Q: What is the minimum order quantity?
A: Our standard MOQ is 25kg, but we offer flexible quantities for sample orders and new customers.
Q: How do you ensure product quality consistency?
A: We implement strict quality control measures at every production stage, use validated analytical methods, and maintain comprehensive quality assurance systems.
Q: What are the available package sizes?
A: Standard packaging is 25kg/drum, but we also offer 1kg, 5kg, and 10kg packages for smaller requirements.
Q: Do you provide samples for testing?
A: Yes, we provide free samples for quality verification and testing purposes.
Q: What is the shelf life of your product?
A: The shelf life is 36 months when stored properly in original packaging under recommended conditions.
Q: Can you customize particle size or other specifications?
A: Yes, we offer customization options for particle size, packaging, and other specific requirements based on customer needs.
Q: What are your shipping terms and delivery time?
A: We offer FOB, CIF, and EXW terms. Delivery time is typically 15-30 days after order confirmation, depending on destination.
Q: Do you provide technical support for formulation development?
A: Yes, our technical team provides comprehensive support for formulation development, regulatory submissions, and quality testing.
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