Quick Facts
| CAS Number | 103980-44-5 |
|---|---|
| Molecular Formula | C19H17N5O7S3 · HCl |
| Molecular Weight | 560.02 (HCl salt) |
| Pharmacopoeia | USP Veterinary, CPV |
| Packaging | 25 KG/DRUM |
Product Overview
Ceftiofur was developed by the Upjohn Company (later Pharmacia & Upjohn, now part of Zoetis) and first approved by the FDA in 1988 as Naxcel. It was the first third-generation cephalosporin designed specifically for veterinary use, and it remains the most commercially successful veterinary cephalosporin globally. Unlike human cephalosporins such as ceftriaxone or cefotaxime that were adapted for animals, ceftiofur was purpose-built for the veterinary market — its pharmacokinetic profile, spectrum of activity, and safety characteristics were optimized for livestock species from the outset.
Ceftiofur is a prodrug: after parenteral administration, it is rapidly metabolized to desfuroylceftiofur, which retains the beta-lactam ring and full antibacterial activity. Desfuroylceftiofur then forms reversible conjugates with cysteine and glutathione, creating a reservoir of active drug that extends the duration of action. This metabolic pathway is the basis for ceftiofur's defining commercial advantage — a single injection of ceftiofur HCl in an oil-based suspension provides 5-7 days of therapeutic coverage for bovine respiratory disease (BRD), and critically, results in zero milk withdrawal in dairy cattle. No other injectable antibiotic used for BRD or metritis offers this combination of single-dose convenience and zero milk discard.
The economic significance of zero milk withdrawal cannot be overstated. A lactating dairy cow treated for metritis or BRD with ceftiofur continues to contribute milk to the bulk tank without interruption, saving an estimated $150–300 per treatment episode in discarded milk. In large dairy operations treating hundreds of cows annually, this single attribute makes ceftiofur the default first-line injectable antibiotic. This feature, combined with broad-spectrum activity against the BRD triad (Mannheimia haemolytica, Pasteurella multocida, Histophilus somni), swine respiratory pathogens (Actinobacillus pleuropneumoniae, Pasteurella multocida, Streptococcus suis), and foot rot (Fusobacterium necrophorum), explains ceftiofur's position as the highest-value veterinary antibiotic API by revenue globally.
As of mid-2026, global ceftiofur API demand is driven by the expanding dairy and beef sectors in Latin America (Brazil, Argentina, Mexico), sustained BRD management in North American feedlots, and growing adoption in Asian dairy markets. API production is technically demanding — the cephalosporin synthesis pathway involves multiple stereospecific steps — and reliable GMP supply remains concentrated among a limited number of Chinese manufacturers. KingWish supplies ceftiofur HCl meeting USP Veterinary and CPV monographs, supporting veterinary pharmaceutical manufacturers serving regulated and emerging markets worldwide.
Quality Specifications
| Purity (HPLC) | ≥ 98.0% (anhydrous basis), per USP Veterinary monograph |
|---|---|
| Related Substances | Desfuroylceftiofur ≤ 1.0%; delta-2 isomer ≤ 1.0%; any individual impurity ≤ 0.5%; total impurities ≤ 2.0% |
| Water Content (Karl Fischer) | ≤ 2.0% (HCl salt specification) |
| Residual Solvents | DMF ≤ 880 ppm; dichloromethane ≤ 600 ppm, per ICH Q3C |
| Heavy Metals | ≤ 20 ppm |
| GMP Status | Manufactured under ICH Q7 GMP conditions |
| Regulatory Support | DMF/ASMF filing documentation available for customer regulatory submissions |
Veterinary Applications
Injectable Oil Suspension (Cattle & Swine)
Ceftiofur HCl 5% sterile suspension. Cattle: 1.0-2.2 mg/kg IM/SC every 24h or single long-acting dose. Zero milk withdrawal. Swine: 3.0-5.0 mg/kg IM for respiratory disease.
Intramammary (Dairy Cattle)
Ceftiofur HCl 500 mg intramammary suspension for clinical mastitis. Labeled for zero milk withholding — a major economic advantage for lactating cow treatment.
Therapeutic Areas
- Cattle: Bovine respiratory disease (BRD), foot rot, acute metritis, mastitis
- Swine: Respiratory disease (A. pleuropneumoniae, P. multocida, S. suis)
- Poultry: Day-old chick mortality prevention (E. coli, Salmonella)
- Sheep/Goats: Respiratory disease, foot infections
Sourcing Ceftiofur HCl: Key Checks
Documentation
Request CoA with full HPLC purity and related substances data — desfuroylceftiofur and delta-2 isomer levels are the critical degradation markers. For regulated markets, confirm DMF/ASMF filing status and request the Letter of Authorization (LoA) for your ANDA/MAA submission.
Red Flags
Elevated desfuroylceftiofur or delta-2 isomer levels (>1.0%) indicate degradation, moisture above 2.0% may cause hydrolysis, reluctance to provide impurity profile data, and suppliers who cannot distinguish between HCl and sodium salt specifications.
Packaging & Logistics
Standard: 25 KG/DRUM. Ceftiofur HCl is moisture-sensitive — store at 2-8°C in tightly sealed containers with desiccant. Standard lead time 8-12 weeks. Cold-chain shipping may be required for tropical destinations.
Market Context
Ceftiofur is the highest-value veterinary antibiotic API by revenue. Global demand is driven by BRD treatment in dairy and beef, with strongest growth in Latin America and Asia. API synthesis is technically demanding with multi-step stereospecific chemistry. Market report