Quick Facts
| CAS Number | 112732-17-9 |
|---|---|
| Molecular Formula | C19H23ClFN3O3 |
| Molecular Weight | 395.86 |
| Pharmacopoeia | IN HOUSE |
| Packaging | 25 KG/DRUM |
Product Overview
Enrofloxacin was developed and patented by Bayer AG in the 1980s as the first fluoroquinolone designed exclusively for veterinary medicine. Launched under the brand name Baytril in 1989, it became the most widely prescribed veterinary fluoroquinolone globally within a decade. Bayer's innovation was recognizing that ciprofloxacin — their human fluoroquinolone — was poorly bioavailable in animals after oral dosing, but adding an ethyl group to the piperazine ring dramatically improved oral absorption and tissue penetration across species. Enrofloxacin is thus a prodrug: in vivo, it is partially N-deethylated to ciprofloxacin, providing a dual-active pharmacokinetic profile unique among veterinary fluoroquinolones.
Enrofloxacin HCL, the hydrochloride salt, addresses the key formulation limitation of enrofloxacin base: water solubility. The base form has limited aqueous solubility (~0.4 mg/mL at neutral pH), making it difficult to formulate as oral solutions, drinking water medications, or injectable liquids. The HCl salt increases water solubility to >100 mg/mL, enabling straightforward preparation of concentrated stock solutions. This is critical for poultry and swine operations where mass medication via drinking water is the standard route of administration — the HCl salt dissolves rapidly and completely without requiring acidification or heating.
Enrofloxacin exerts its bactericidal effect through dual inhibition of bacterial DNA gyrase (topoisomerase II) and topoisomerase IV — the two enzymes responsible for DNA supercoiling, replication, and chromosome segregation. This dual-target mechanism gives enrofloxacin concentration-dependent bactericidal activity against a remarkably broad spectrum: Gram-negative bacteria (E. coli, Salmonella, Pasteurella, Haemophilus, Actinobacillus, Pseudomonas), Gram-positive bacteria (Staphylococcus, Streptococcus), Mycoplasma species, and intracellular pathogens (Brucella, Chlamydia, Mycobacterium). Its ability to penetrate intracellular compartments and achieve therapeutic concentrations within macrophages is essential for clearing facultative intracellular pathogens that are inaccessible to many other antibiotic classes.
As of mid-2026, global enrofloxacin demand is driven by sustained poultry production growth in Southeast Asia, Latin America, and the Middle East, where respiratory and enteric bacterial infections remain the most economically damaging diseases. China accounts for the dominant share of global enrofloxacin API production, with manufacturing concentrated in Zhejiang, Shandong, and Henan provinces. Regulatory landscapes vary significantly — the US restricts fluoroquinolone use in food animals, while most Asian, African, and Latin American countries permit enrofloxacin under veterinary prescription with species-specific withdrawal periods. KingWish supplies GMP-certified enrofloxacin HCl manufactured under ICH Q7 conditions, supporting veterinary pharmaceutical formulators in regulated and emerging markets.
Quality Specifications
| Assay (HPLC) | ≥ 98.0% (dried basis), per IN HOUSE standard |
|---|---|
| Water Content (KF) | ≤ 5.0% |
| Related Substances | Individual impurity ≤ 0.5%, ciprofloxacin impurity controlled separately |
| Heavy Metals | ≤ 20 ppm |
| Residual Solvents | Compliant with ICH Q3C |
| GMP Status | Manufactured under ICH Q7 GMP conditions |
Veterinary Applications
Poultry Respiratory Infections
Administered via drinking water for treatment of colibacillosis, fowl cholera, chronic respiratory disease, and mycoplasmosis in broilers and layers.
Swine & Companion Animals
Bacterial enteritis, respiratory infections in swine. Skin and soft tissue infections, urinary tract infections, and respiratory infections in dogs and cats.
Therapeutic Areas
- Poultry: Respiratory infections, colibacillosis, mycoplasmosis
- Swine: Bacterial enteritis, respiratory infections
- Cattle: Bovine respiratory disease (BRD), pneumonia
- Companion Animals: Skin infections, UTIs, respiratory infections
Sourcing Enrofloxacin HCL: Key Checks
Documentation
Request CoA with HPLC assay (≥98.0%), water content (KF, ≤5.0%), related substances profile (with separate ciprofloxacin control), and residual solvent statement. Confirm GMP certificate (ICH Q7) is current and issued by a recognized authority. For EU-bound product, verify absence of ethylene glycol as a residual solvent. DrugBank reference
Red Flags
Elevated ciprofloxacin content (indicates degradation or poor manufacturing controls), water content above 5% (incomplete drying), pH outside expected range when reconstituted, reluctance to share batch-specific HPLC chromatograms, and suppliers offering enrofloxacin HCl at base-form prices.
Packaging & Logistics
Standard: 25 KG/DRUM with PE liner. Store at room temperature (15-25 degrees C), protected from light. Enrofloxacin HCL is photosensitive — prolonged exposure to direct sunlight should be avoided. Shelf life typically 36 months. Custom packaging available for formulators requiring smaller or alternative drum sizes.
Market Context
Enrofloxacin is one of the highest-volume veterinary antibiotic APIs globally. China dominates production (>70% global supply). Market growth is driven by poultry expansion in Southeast Asia and Africa. Regulatory restrictions in the US and EU are partially offset by growth in emerging markets. The enrofloxacin-ciprofloxacin metabolic relationship is a key differentiator in marketing and technical positioning.