Ceftiofur Hydrochloride API Manufacturer China | ≥98% Third-Generation Cephalosporin Veterinary Antibiotic CAS 103980-44-5
Key Selling Points
✓ Ready-to-Use Injectable Suspension API - No Reconstitution Needed (vs Sodium Salt)
✓ Depot Effect & Longer Duration - Sustained Release from IM/SC Suspension
✓ Third-Gen Cephalosporin - β-Lactamase-Stable Broad Gram+/Gram− Spectrum
✓ BRD & Swine Respiratory Gold Standard - Mannheimia, Pasteurella, Actinobacillus, Streptococcus
✓ Bovine Foot Rot & Metritis - Fusobacterium necrophorum Anaerobic Coverage
✓ Wide Safety Margin - 25× Dose in Swine No Systemic Toxicity; Not for Poultry (AMR Risk)
What Is Ceftiofur Hydrochloride Powder?
Ceftiofur Hydrochloride Powder is the hydrochloride salt of ceftiofur (C₁₉H₁₇N₅O₇S₃·HCl, MW 560.02), the first third-generation cephalosporin developed exclusively for veterinary medicine. Unlike the sodium salt (freely water-soluble, sterile powder requiring reconstitution), the hydrochloride is typically formulated as a ready-to-use injectable suspension (e.g., Excenel RTU, Citius, Eficur) with depot/sustained-release characteristics, requiring no reconstitution before IM/SC administration.
Antibacterial spectrum is identical to the sodium salt: active against Gram-positive (Streptococcus, susceptible Staphylococcus), Gram-negative (E. coli, Pasteurella multocida, Mannheimia haemolytica, Histophilus somni, Actinobacillus pleuropneumoniae, Salmonella) and anaerobic (Fusobacterium necrophorum) organisms, but not Pseudomonas, Enterococcus, Mycoplasma or Chlamydia. Veterinary indications include bovine respiratory disease (BRD), bovine foot rot and acute metritis, swine respiratory disease, equine/ovine/caprine respiratory infections. Not approved for use in poultry (including eggs) due to risk of antimicrobial resistance spread to humans. Main safety concerns: injection site reactions (tissue oedema, discoloration of fascia/fat/muscle, may persist 10–20 days), rare cephalosporin hypersensitivity (possible cross-reactivity with penicillins), and meat/milk withdrawal periods.
How Does Ceftiofur Hydrochloride Powder Work?
Ceftiofur Hydrochloride Powder exerts bactericidal activity through β-lactam inhibition of penicillin-binding proteins (PBPs), blocking the final transpeptidation step in bacterial cell wall peptidoglycan synthesis, weakening the wall and causing osmotic lysis in actively dividing bacteria.
Because Ceftiofur Hydrochloride Powder is time-dependent (efficacy correlates with time above MIC), the depot suspension formulation maintains therapeutic concentrations longer than the reconstituted sodium salt, supporting once-daily dosing. The aminothiazole-methoxyimino side chain confers stability against many plasmid-mediated β-lactamases and broad Gram-negative coverage; the 3-position furanylcarbonylthiomethyl group is metabolized to desfuroylceftiofur (still active). It does not resist AmpC chromosomal β-lactamases or ESBLs. Excretion is primarily renal and biliary. Not active against Pseudomonas aeruginosa, Enterococcus, Mycoplasma or Chlamydia. The hydrochloride counter-ion is pharmacologically inert but reduces aqueous solubility, enabling suspension formulation and depot release.
What Are the Applications of Ceftiofur Hydrochloride Powder?
- Bovine Respiratory Disease (BRD): Treatment of Mannheimia haemolytica, Pasteurella multocida and Histophilus somni infections in cattle (including lactating dairy cows), via ready-to-use IM/SC suspension.
- Bovine Foot Rot & Metritis: Fusobacterium necrophorum infections - interdigital necrobacillosis (foot rot) and acute postpartum metritis.
- Swine Respiratory Disease: Pasteurella multocida, Actinobacillus pleuropneumoniae, Streptococcus suis, Haemophilus spp., Salmonella choleraesuis and E. coli infections in pigs.
- Equine & Small Ruminant: Respiratory infections in horses, sheep and goats.
- Not for Poultry: Use in poultry (including eggs) is contraindicated due to antimicrobial resistance spread risk.
What Is the Difference Between Ceftiofur Hydrochloride and Ceftiofur Sodium?
| Feature | Ceftiofur Hydrochloride | Ceftiofur Sodium |
|---|---|---|
| CAS | 103980-44-5 | 104010-37-9 |
| Counter-Ion | Hydrochloride | Sodium |
| Molecular Weight | 560.02 | ~545.5 |
| Water Solubility | Soluble (less freely) | Freely soluble |
| Typical Form | Ready-to-use injectable suspension | Sterile powder for reconstitution |
| Reconstitution | Not required | Required before use |
| Route | IM / SC (suspension) | IM / IV (solution) |
| Duration | Longer (depot/sustained release) | Shorter (24 hr dosing) |
| Injection Site Reaction | More common (oedema, discoloration) | Less common |
| Poultry Use | Contraindicated (AMR risk) | Approved for day-old chicks |
| Antibacterial Activity | Identical | Identical |
How Does Ceftiofur Compare With Other Veterinary Cephalosporins?
| Feature | Ceftiofur (HCl) | Cefquinome | Cefazolin | Cephalexin |
|---|---|---|---|---|
| CAS (salt) | 103980-44-5 | 84957-30-2 | 25953-19-9 | 15686-71-2 |
| Generation | 3rd | 4th | 1st | 1st |
| β-Lactamase Stability | High | Very high | Low | Low |
| Gram-Negative | Broad | Very broad | Narrow | Narrow |
| Anaerobic | Yes (Fusobacterium) | Moderate | No | No |
| Pseudomonas | No | Yes | No | No |
| Formulation | RTU suspension | Sterile powder | Sterile powder | Oral |
| Typical Use | BRD, foot rot, swine | Bovine mastitis, BRD | Surgical prophylaxis | Canine skin/UTI |
How Is Ceftiofur Hydrochloride Powder Manufactured?
Ceftiofur Hydrochloride Powder is manufactured through multi-step semi-synthesis from 7-ACA (7-aminocephalosporic acid), involving side-chain acylation, 3-position substitution and hydrochloride salt formation.
Raw Material QC → 7-ACA Preparation → 7-Position Acylation (Aminothiazole-Methoxyimino Acetic Acid) → 3-Position Substitution (Furanylcarbonylthiomethyl) → Purification (Chromatography) → Hydrochloride Salt Formation (HCl / Hydrochloric Acid) → Crystallization → Drying → Milling → Final QC → Packaging
HDM BIO controls key acylation, substitution and salt formation parameters to maintain consistent purity, β-lactam integrity and batch quality.
Quality Specifications
| Test Item | Standard | Typical Result |
|---|---|---|
| Appearance | White to off-white powder | Consistent |
| Assay (HPLC) | ≥98.0% | 99.0% |
| Identity (IR / HPLC) | Conforms to reference standard | Confirmed |
| pH (10% solution) | 3.0–6.0 | 4.5 |
| Water Content (Karl Fischer) | ≤3.0% | 1.0% |
| Specific Optical Rotation | −30° to −50° | −40° |
| Related Substances | Within specification | Pass |
| Desfuroylceftiofur | ≤1.0% | Compliant |
| Heavy Metals | ≤10 ppm | Compliant |
| Residual Solvents | Within specification | Pass |
What Quality Control Tests Are Performed for Ceftiofur Hydrochloride Powder?
Each batch undergoes multi-step quality control before release to verify identity, purity and β-lactam integrity.
Raw Material QC → In-Process Control → HPLC Assay → IR Identity Verification → pH Determination → Karl Fischer Water Content → Specific Optical Rotation → Related Substances (HPLC, incl. desfuroylceftiofur) → Heavy Metals → Residual Solvents → Final Batch Release
Key evaluations include HPLC assay (≥98%), IR identity, pH, Karl Fischer water content, specific optical rotation, related substances with specific desfuroylceftiofur limit, heavy metals and residual solvents. Every commercial batch is supported by a batch-specific COA and relevant analytical documentation for incoming QC and supplier qualification.
What Factors Affect Ceftiofur Hydrochloride Powder Bulk Price?
Ceftiofur Hydrochloride Powder bulk pricing is driven by several key factors:
- Raw Material Costs: 7-ACA and specialized side-chain intermediates directly influence manufacturing expenses.
- Purity & Grade: ≥98% HPLC API with full documentation commands a premium over technical grade.
- Regulatory Compliance & Certification: GMP-standard veterinary API with complete COA demands a higher price.
- Order Volume: Large-scale veterinary pharmaceutical contracts receive steeper per-kilogram discounts.
- Logistics & Geography: Cold-chain (2–8°C) / light-protected / moisture-proof packaging and customs compliance add to the landed cost.
Contact HDM BIO for a current quotation and volume-based pricing.
Why Choose HDM BIO as Your Ceftiofur Hydrochloride Powder Supplier?
- High-purity (≥98% / typical 99%) veterinary-exclusive third-generation cephalosporin for ready-to-use suspension formulations
- Verified β-lactamase stability and broad spectrum; low desfuroylceftiofur impurity; consistent hydrochloride salt formation
- Gold-standard BRD, foot rot and swine respiratory API with depot/sustained-release suspension characteristics
- GMP-aligned production, ISO & HACCP certified quality system
- Full batch traceability and complete documentation (COA, MSDS, HPLC)
- Flexible supply: kilogram samples to ton-level bulk API orders
- Global export to 70+ countries with full customs support
Bulk Packaging, Shipping & Storage
- Packaging: Foil bags for samples and moisture-proof fiber drums for bulk orders.
- Custom Packaging: OEM labeling available.
- Shipping Documents: COA, MSDS/SDS, commercial invoice, packing list and customs documentation available according to order requirements.
- Storage: Store tightly sealed at 2–8°C in a dry, light-protected environment. Shelf life: 24 months.
- Handling: For veterinary raw material use only; not for direct clinical administration.
Frequently Asked Questions About Ceftiofur Hydrochloride Powder
Q1: What is Ceftiofur Hydrochloride Powder?
A: Ceftiofur hydrochloride is the hydrochloride salt of ceftiofur, the first third-generation cephalosporin developed exclusively for veterinary medicine. It is typically formulated as a ready-to-use injectable suspension (no reconstitution needed) with depot/sustained-release characteristics, used for bovine respiratory disease, foot rot, metritis and swine respiratory disease.
Q2: What is the CAS number?
A: 103980-44-5.
Q3: How does ceftiofur hydrochloride work?
A: It inhibits penicillin-binding proteins (PBPs), blocking bacterial cell wall peptidoglycan synthesis and causing osmotic lysis. It is bactericidal, time-dependent, and stable against many plasmid-mediated β-lactamases. The suspension formulation provides depot release for longer duration.
Q4: What is the difference between ceftiofur hydrochloride and sodium?
A: Antibacterial activity is identical. The hydrochloride is less water-soluble and formulated as a ready-to-use IM/SC suspension with depot effect (no reconstitution), but causes more injection site reactions and is contraindicated in poultry. The sodium salt is freely soluble, supplied as sterile powder requiring reconstitution for IM/IV, and approved for day-old chicks.
Q5: What is ceftiofur hydrochloride used for?
A: Bovine respiratory disease (Mannheimia, Pasteurella, Histophilus), bovine foot rot and acute metritis (Fusobacterium), swine respiratory disease (Pasteurella, Actinobacillus, Streptococcus, Haemophilus, Salmonella, E. coli), equine/ovine/caprine respiratory infections. Not for poultry.
Q6: What documents are provided with each batch?
A: Batch-specific COA, HPLC assay report, IR identity, pH, Karl Fischer water content, optical rotation, related substances (incl. desfuroylceftiofur), heavy metals, residual solvents, MSDS/SDS.
Q7: What purity do you supply?
A: Standard ≥98.0% HPLC; typical batch result 99%.
Q8: Where can I buy it from China?
A: HDM BIO supplies bulk Ceftiofur Hydrochloride Powder with batch COA and global export support.
Q9: How much does Ceftiofur Hydrochloride Powder cost?
A: Bulk pricing depends on 7-ACA/side-chain raw material costs, purity/grade, regulatory compliance, order volume and logistics. Contact HDM BIO for a current quotation.
Q10: Are there any safety concerns?
A: Wide safety margin (25× dose in swine for 5 days no systemic toxicity). Injection site reactions are common: tissue oedema and discoloration of fascia/fat/muscle, may persist 10–20 days and can extend beyond pre-slaughter withdrawal. Rare cephalosporin hypersensitivity (possible cross-reactivity with penicillins). Meat/milk withdrawal periods apply. Contraindicated in poultry (AMR spread risk). Shake suspension well before use. Cold-chain storage (2–8°C) required. Not for human use.
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