Pharmaceutical Raw Materials Antibacterial Drugs Oxytetracycline Hydrochloride CAS 2058-46-0
CAS:2058-46-0
Appearance: Yellow crystalline powder
Purity:≥95%
Solubility:Freely soluble in water, sparingly soluble in ethanol.
Product Introduction
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Reliable Veterinary-Grade Broad-Spectrum Tetracycline
Oxytetracycline Hydrochloride (CAS: 2058-46-0) stands as a foundational and widely trusted broad-spectrum tetracycline antibiotic in veterinary medicine. Esteemed for its extensive activity against a diverse range of Gram-positive and Gram-negative bacteria, as well as Mycoplasma, Rickettsiae, and Chlamydiae, it remains an essential active pharmaceutical ingredient (API) for managing common and challenging infections in livestock and poultry globally.
This API is highly valued for its versatility in formulation, readily used in high-efficacy injectables, oral solutions, and feed premixes. Oxytetracycline Hydrochloride provides a cost-effective and dependable solution for preventing and treating a myriad of conditions, including respiratory, gastrointestinal, and urinary tract infections, ensuring animal health and productivity across diverse agricultural settings.
Established Broad-Spectrum Efficacy
Proven effectiveness against a wide array of bacterial pathogens, offering comprehensive control over various animal diseases.
High Solubility & Versatile Application
Its hydrochloride salt form ensures excellent solubility, allowing for flexible formulation into injectables, oral solutions, and feed additives.
Trusted & Cost-Effective Solution
A long history of safe and effective use, combined with favorable economics, makes it a preferred choice for animal health manufacturers.
Product Specification
1. Name and Identification
The active pharmaceutical ingredient is Oxytetracycline Hydrochloride, identified by its CAS No. 2058-46-0. It is a potent tetracycline antibiotic, widely recognized for its broad-spectrum antibacterial activity in diverse veterinary formulations.
2. Chemical Characteristics
Oxytetracycline Hydrochloride functions by inhibiting bacterial protein synthesis, effectively halting bacterial growth (bacteriostatic action). This mechanism allows it to combat a broad spectrum of susceptible pathogens by reversibly binding to the 30S ribosomal subunit.
3. Physical Properties
Typically, Oxytetracycline Hydrochloride appears as a yellow, crystalline powder. It exhibits good solubility in water, making it highly suitable for various liquid and solid dosage forms in animal health products. Our material ensures consistent quality and stability under recommended storage conditions.
4. Quality Specifications and Standards
| Test Parameter | Specification |
|
Shelf Life |
2 years from manufacturing date |
|
Appearance |
Yellow crystalline powder |
|
Identification |
- Positive by HPLC, IR absorption & color reaction |
|
Water Content |
≤ 5.0% (Karl Fischer method) |
|
pH (1% w/v solution) |
2.0 – 3.0 |
|
Clarity & Color of Solution |
Clear yellow solution |
|
Assay (Oxytetracycline) |
≥ 95.0% (on anhydrous basis) |
|
Related Substances |
- Epioxytetracycline ≤ 2.0% |
|
Heavy Metals |
≤ 20 ppm |
|
Residue on Ignition |
≤ 0.5% |
|
Crystallinity |
Complies with Pharmacopoeia tests |
5. Key Veterinary Applications
Our Oxytetracycline Hydrochloride API is a cornerstone for creating effective veterinary formulations targeting:
- Treatment of various bacterial infections in cattle, pigs, sheep, goats, and poultry, including respiratory diseases (e.g., shipping fever, pneumonia).
- Management of gastrointestinal infections (e.g., bacterial enteritis, scours).
- Control of urinary tract infections and other systemic bacterial diseases.
- Effective against specific conditions such as Anaplasmosis in cattle, fowl cholera, and sinusitis in poultry.
- Ideal for high-quality injectable solutions, oral powders, water-soluble premixes, and feed additives.
Key Properties
Pharmacological Profile in Animal Systems
Oxytetracycline Hydrochloride is a cornerstone broad-spectrum tetracycline, highly valued in veterinary medicine for its versatile and potent action:
- Mechanism of Action: It exerts its bacteriostatic effect by inhibiting bacterial protein synthesis. Specifically, it reversibly binds to the 30S ribosomal subunit, preventing the attachment of aminoacyl tRNA to the ribosomal acceptor site and thus disrupting peptide chain elongation.
- Spectrum of Activity: Demonstrates powerful activity against a wide array of Gram-positive bacteria (e.g., Staphylococcus aureus, Streptococcus spp.), Gram-negative bacteria (e.g., E. coli, Pasteurella multocida, Salmonella spp.), as well as Mycoplasma, Rickettsiae, and Chlamydiae.
- Pharmacokinetics in Animals: Following administration (oral or parenteral), Oxytetracycline is well-absorbed and widely distributed throughout various body tissues, including lungs, liver, kidneys, and bone. It is primarily excreted through both the kidneys and bile, ensuring sustained therapeutic levels.
- Stability in Formulations: As a hydrochloride salt, Oxytetracycline is exceptionally stable and highly soluble in water, making it an ideal API for robust liquid injectables, oral solutions, and finely dispersed feed premixes with reliable efficacy.
Essential Chemical Attributes
- pH in Solution: A 1% aqueous solution typically exhibits an acidic pH, generally ranging from 2.0 to 3.0, crucial for formulation stability.
- Thermal Stability: The crystalline powder maintains excellent stability under recommended storage conditions, requiring protection from excessive heat.
- Light Sensitivity: As with most tetracyclines, it should be stored in light-resistant containers to prevent photolytic degradation and maintain potency.
- Hygroscopicity: Possesses some hygroscopic properties. For optimal integrity, containers should be kept tightly sealed to shield against moisture absorption.
- Solubility Characteristics: Readily soluble in water, facilitating the preparation of clear and effective aqueous solutions for various administration routes.
Versatile Applications Across Animal Species
Our veterinary-grade Oxytetracycline Hydrochloride API is a primary choice for addressing critical health issues in a diverse range of animals:
- Cattle: Indispensable for treating Bovine Respiratory Disease (BRD), anaplasmosis, bacterial enteritis, foot rot, and various bacterial mastitis cases.
- Swine: Highly effective against Swine Respiratory Disease (SRD), bacterial enteritis (e.g., swine dysentery), and certain systemic infections.
- Poultry: Crucial for controlling and treating Chronic Respiratory Disease (CRD), Fowl Cholera, Infectious Coryza, and bacterial enteritis.
- Sheep & Goats: Used for treating pneumonia, foot rot, and bacterial enteritis, among other susceptible infections.
Rigorous Quality Control
Our Unwavering Commitment to API Quality
Every batch of Oxytetracycline Hydrochloride is produced under the most stringent quality control protocols, consistently meeting and exceeding global veterinary pharmaceutical standards.
Comprehensive Analytical Testing:
- HPLC Analysis: Precisely determines assay, purity, and identifies related substances and degradation products.
- Spectroscopy (UV/IR): Utilized for definitive identity confirmation and structural verification of the compound.
- Microbiological Purity: Rigorous testing ensures compliance with stringent limits for bacterial endotoxins and overall microbial contamination.
- Water Content: Accurately measured by Karl Fischer titration to ensure optimal stability and formulation consistency.
- Residual Solvents Analysis: Performed via Gas Chromatography (GC) to guarantee safety and full compliance with ICH guidelines.
Veterinary-Specific Quality Assurance:
Our Oxytetracycline Hydrochloride API is manufactured in dedicated, state-of-the-art GMP-certified facilities. Each shipment is meticulously prepared, accompanied by a comprehensive Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), and complete batch traceability documentation, ensuring full transparency and compliance.
Stability and Regulatory Compliance:
Our API undergoes extensive, real-time and accelerated stability testing in strict adherence to ICH guidelines. It is fully compliant with all major international veterinary pharmacopoeial standards, including but not limited to the European Pharmacopoeia (EP) and Chinese Veterinary Pharmacopoeia (CPV).
Robust Regulatory and Safety Framework:
- Adherence to major pharmacopoeias such as the European Pharmacopoeia (EP) and Chinese Veterinary Pharmacopoeia (CPV).
- Production takes place in audited, GMP-compliant facilities specifically designed and approved for veterinary API manufacturing.
- A comprehensive batch release protocol is rigorously executed by our expert quality assurance team before any material is authorized for dispatch.
Packaging & Transportation
We prioritize the safe and secure delivery of your Oxytetracycline Hydrochloride, utilizing robust, stability-maintaining packaging and offering flexible, reliable global transportation solutions to meet your specific logistical needs.
Packaging Options
Export-Standard Packaging
1kg foil bags – Ideal for samples and initial trial runs.
25kg fiber drums – Equipped with double PE liners for bulk commercial requirements.
Custom packaging – Available upon specific request to meet unique client specifications.
Pharma-grade materials – All packaging materials are moisture-proof, contamination-resistant, and compliant with pharmaceutical standards.
Transportation Options
Global Logistics Solutions
Express Courier – DHL, FedEx, TNT for rapid delivery of small or urgent orders.
Air Freight – The optimal choice for mid-volume, time-sensitive shipments to global destinations.
Sea Freight – A highly cost-effective solution for large bulk orders, offering efficient worldwide shipping.
Lead Time – Efficient dispatch typically within 2–3 business days following payment confirmation.
Partner with a Fully Certified API Supplier
Veterinary Compliance & Accreditation
- Veterinary GMP Certified: All our Oxytetracycline Hydrochloride is manufactured under the most stringent veterinary Good Manufacturing Practice (GMP) standards, ensuring peak quality and safety.
- ISO 9001:2015 Certified: Our comprehensive quality management system is fully certified to ISO 9001:2015, guaranteeing consistent product quality and highly efficient process control.
- ISO 14001:2015 Certified: We proudly adhere to certified environmental management standards (ISO 14001:2015), reflecting our commitment to sustainable and responsible production practices.
- Full Documentation Support: Every order of Oxytetracycline Hydrochloride includes a complete set of essential documents: a detailed Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), comprehensive batch traceability report, and all necessary shipping papers.
Veterinary GMP
ISO 9001:2015
ISO 14001:2015
Frequently Asked Questions
Frequently Asked Questions About Oxytetracycline Hydrochloride
Q1: Can I request a sample of Oxytetracycline Hydrochloride?
Yes, we provide complimentary samples for laboratory evaluation and formulation development. Please note that international courier charges are typically covered by the customer.
Q2: What are the main veterinary uses of Oxytetracycline Hydrochloride?
Oxytetracycline Hydrochloride is widely used in veterinary medicine to treat respiratory infections (such as pneumonia and shipping fever), gastrointestinal conditions (like bacterial enteritis), urinary tract infections, and vector-borne diseases such as anaplasmosis. It is commonly applied in cattle, swine, and poultry.
Q3: What is the shelf life of your Oxytetracycline Hydrochloride?
The standard shelf life is 24 months from the date of manufacture when stored in its original sealed packaging, in a dry, cool place away from direct sunlight.
Q4: Do you offer DDP (Delivered Duty Paid) shipping options?
Yes. Delivered Duty Paid (DDP) terms are available depending on the destination country and the size of the order. Please contact our logistics team for specific arrangements based on your import regulations.
Q5: What documentation is provided with each shipment?
Each shipment includes a Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Commercial Invoice, and Packing List. Additional documents such as GMP certificates or ISO compliance records can be provided upon request.
Q6: What are the withdrawal periods for Oxytetracycline in food-producing animals?
Withdrawal periods vary by species, administration method, and local regulations. Generally:
• Cattle (meat): 28 days
• Cattle (milk): 96 hours
• Swine (meat): 28 days
Please always follow the instructions approved by your local regulatory authorities or final product label.
Q7: What class of antibiotic is Oxytetracycline Hydrochloride?
Oxytetracycline belongs to the tetracycline class of antibiotics. It is a bacteriostatic agent that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit.
Q8: Are there common side effects associated with Oxytetracycline?
Oxytetracycline is generally safe and well-tolerated. Mild side effects may include localized swelling at the injection site or digestive discomfort in oral use. In young animals, prolonged use may cause tooth discoloration. Severe adverse reactions are rare when used correctly.
Q9: Can Oxytetracycline be used in lactating dairy cows?
Yes. Oxytetracycline is approved for treating certain infections, including mastitis, in lactating dairy cows. Be sure to observe the designated milk withdrawal periods to comply with residue regulations.
Q10: How does Oxytetracycline differ from beta-lactam antibiotics such as Penicillin or Cephalosporins?
Oxytetracycline is bacteriostatic and works by blocking protein synthesis, whereas beta-lactams are bactericidal and target bacterial cell wall synthesis. Oxytetracycline also covers a broader spectrum, including intracellular organisms like Mycoplasma and Chlamydia, which are typically not addressed by beta-lactams.
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