Chlortetracycline hydrochloride is a broad-spectrum tetracycline active pharmaceutical ingredient produced via controlled fermentation and crystallization, engineered specifically for veterinary formulation and medicated feed manufacturing with high dry-blend stability and rapid aqueous solubility.
Technical Specifications
|
Parameter |
Specification Limit |
Test Method / Note |
|
Assay (Potency) |
≥ 890 µg/mg |
Anhydrous basis, pharmacopeial standard |
|
PH Value |
2.3 - 3.3 |
1% aqueous solution |
|
Loss on Drying |
≤ 2.0% |
Vacuum drying controlled |
|
Residue on Ignition |
≤ 0.5% |
Inorganic contaminant limit |
|
Heavy Metals |
≤ 20 ppm |
Atomic absorption spectroscopy |
|
Particle Size (D90) |
< 150 µm |
Optimized for dry-blending homogeneity |
Chemical & Pharmacological Profile
Mechanism of Action: Binds reversibly to the 30S ribosomal subunit of susceptible pathogens, blocking aminoacyl-tRNA attachment to halt bacterial protein synthesis.
Spectrum of Activity: Active against Gram-positive and Gram-negative bacteria, including Pasteurella, Escherichia coli, Salmonella, and Mycoplasma species.
Physicochemical Properties: Yellow crystalline powder, odorless, slightly bitter taste, sparingly soluble in water, practically insoluble in ether and chloroform.
Processing & Formulation Focus
Dust Reduction: Controlled milling limits airborne dust generation during handling while maintaining powder flowability.
Thermal Stability: Optimized crystal structure resists degradation during high-temperature feed pelleting processes.
Aqueous Performance: Dissolves completely without sedimentation, helping prevent pipeline clogging in automated drinking water systems.
Veterinary Applications
Soluble Powders: Formulated for oral administration via livestock drinking water for veterinary treatment applications.
Medicated Premixes: Blended into swine and poultry feed formulations for veterinary use.
Injectable Formulations: Processed for veterinary parenteral suspension formulations requiring controlled bioburden.
Impurity Control Profile
Related Substances: Individual degradation products and process-related impurities are quantified using high-performance liquid chromatography.
Degradation Control: 4-Epianhydrochlortetracycline and related degradation compounds are monitored and controlled according to applicable quality specifications.
Microbial Load: Total aerobic microbial count, yeast, mold, and specified microorganisms are tested according to applicable quality requirements.
Quality Assurance & Testing
Method Validation: Analytical procedures are validated for accuracy, linearity, and precision according to applicable analytical guidelines.
Lot Traceability: Complete raw material records and fermentation parameter records are maintained for every production lot.
Stability Studies: Real-time and accelerated stability studies are conducted to establish shelf-life under defined storage conditions.
Regulatory Support & Documentation
Certificate of Analysis: A batch-specific Certificate of Analysis is supplied with each commercial shipment.
Safety Data Sheet: Safety Data Sheets covering handling, storage, and hazard information are provided in standard global formats.
Technical Dossier: Manufacturing process information, impurity profiles, and analytical method documentation can be provided to support local registration and technical evaluation.
Storage Conditions
Temperature: Store below 25°C in a cool, dry area protected from direct sunlight.
Moisture Protection: Keep containers tightly sealed and protected from moisture to help maintain product stability.
Shelf Life: 36 months from the date of manufacture when stored under recommended conditions.
Packaging & Logistics
Primary Container: Double-layer low-density polyethylene bags securely sealed to minimize moisture ingress.
Secondary Container: Rigid fiber drums providing additional physical protection during international transportation.
Standard Unit: 25 kg net weight per drum, equipped with tamper-evident seals.
Frequently Asked Questions
Q: What is the standard minimum order quantity for commercial batches?
A: The standard minimum order quantity is 100 kg, typically packaged in standard 25 kg fiber drums.
Q: Are analytical reference standards provided for laboratory validation?
A: Representative analytical reference samples and corresponding documentation can be supplied upon client request.
Q: How is batch consistency verified prior to dispatch?
A: Each production lot undergoes testing against established quality specifications. A corresponding Certificate of Analysis is issued before shipment.
Q: What documentation accompanies international freight?
A: Shipments can be supplied with standard commercial invoices, packing lists, Certificates of Analysis, Safety Data Sheets, and other applicable export documentation.
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