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Florfenicol

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Florfenicol molecular structure
Quick Facts
CAS Number73231-34-2
Molecular FormulaC12H14Cl2FNO4S
Molecular Weight358.21
PharmacopoeiaCVP, IN HOUSE
Packaging25 KG/DRUM
GMP Certified

Product Overview

Florfenicol was developed by Schering-Plough Corporation (now part of Merck Animal Health) and launched in the 1990s as Nuflor. Its development was driven by an urgent regulatory problem: chloramphenicol, the most important amphenicol antibiotic against respiratory pathogens, had been banned from food-animal use in the United States (1985) and Europe (1994) due to a rare but fatal idiosyncratic aplastic anemia risk in humans. Thiamphenicol, the immediate chloramphenicol analog, had a better safety profile but was susceptible to the same bacterial acetylation-based resistance mechanism. Florfenicol solved both problems in a single molecule.

The critical structural innovation was replacing the C-3 hydroxyl group of thiamphenicol with a fluorine atom. This single-atom substitution achieved two goals simultaneously: (1) The fluorine atom is not a substrate for bacterial chloramphenicol acetyltransferase (CAT), making florfenicol active against chloramphenicol- and thiamphenicol-resistant strains. (2) The molecule lacks the p-nitro group of chloramphenicol — the moiety responsible for aplastic anemia — resulting in a fundamentally different toxicological profile that allowed regulatory approval for food animals. This elegant structural design made florfenicol the first amphenicol-class antibiotic approved for use in food-producing animals, setting the stage for its widespread adoption across aquaculture, cattle, swine, and poultry sectors.

Florfenicol is now the dominant veterinary antibiotic in global aquaculture, where its broad-spectrum activity against aquatic pathogens (Aeromonas salmonicida, Vibrio anguillarum, Streptococcus iniae, Edwardsiella ictaluri) and stability in medicated feed make it the first-line treatment for bacterial disease outbreaks in finfish and shrimp. In terrestrial livestock, its excellent lung tissue penetration — achieving lung-to-plasma ratios well above 1 — makes it a first-line injectable for bovine respiratory disease (BRD). The aquaculture sector accounts for the largest volume share of global florfenicol consumption, driven by the rapid expansion of intensive aquaculture production in China, Vietnam, India, Indonesia, and Ecuador.

As of mid-2026, the global florfenicol API market continues to grow at approximately 5-7% annually, led by aquaculture demand in Asia-Pacific and Latin America. China is the dominant producer, with API synthesis concentrated in Shandong, Zhejiang, and Hubei provinces. Key quality considerations include enantiomeric purity, particle size distribution for feed-grade products, and stringent residual solvent control. KingWish supplies GMP-certified florfenicol meeting CVP and in-house standards validated against international pharmacopoeia requirements, supporting veterinary pharmaceutical and feed manufacturers worldwide.

Quality Specifications

Purity (HPLC)≥ 98.0%, per CVP/IN HOUSE monograph
Related SubstancesThiamphenicol ≤0.5%; any individual impurity ≤0.5%; total ≤2.0%
Enantiomeric PurityChiral HPLC confirms single enantiomer; meets pharmacopoeia specifications for stereochemical purity
Residual SolventsMethanol ≤ 3,000 ppm; ethyl acetate ≤ 5,000 ppm; per ICH Q3C
Heavy Metals≤ 20 ppm (aquaculture-grade meets stricter limits per importing country requirements)
GMP StatusManufactured under ICH Q7 GMP conditions

Veterinary Applications

Aquaculture (Feed Premix)

Florfenicol 10-50% feed premix. Fish: 10 mg/kg BW/day for 10 days for furunculosis, vibriosis, streptococcosis. Shrimp: medicated feed for Vibrio and NHP bacteria. Particle size critical for feed homogeneity.

Injectable (Cattle & Swine)

Florfenicol 300 mg/mL injectable solution. Cattle: 20 mg/kg IM (single dose) or 40 mg/kg SC for BRD. 28-day meat withdrawal. Swine: 15 mg/kg IM every 48h for respiratory disease.

Therapeutic Areas

  • Aquaculture: Furunculosis, vibriosis, streptococcosis, columnaris disease, edwardsiellosis
  • Cattle: Bovine respiratory disease (BRD), interdigital phlegmon
  • Swine: Respiratory disease, atrophic rhinitis, Glasser's disease
  • Poultry: Colibacillosis, infectious coryza, pasteurellosis

Sourcing Florfenicol: Key Checks

Documentation

Request CoA with HPLC purity, enantiomeric purity (chiral HPLC), and related substances data. Thiamphenicol content is a key quality indicator — it should be well below 0.5%. For aquaculture, also request particle size distribution data.

Red Flags

Elevated thiamphenicol as an impurity (>0.5%) suggests incomplete fluorination during synthesis. High residual methanol or ethyl acetate indicates poor process control. Prices significantly below market — florfenicol synthesis is multi-step and has a real cost floor.

Packaging & Logistics

Standard: 25 KG/DRUM. Custom packaging and micronized grades available. Store at room temperature (15-30°C), protected from light. Standard lead time 4-8 weeks. Aquaculture-grade may require different packaging specifications.

Market Context

Global florfenicol market grows at 5-7% annually, led by aquaculture expansion in Asia-Pacific and Latin America. China accounts for >80% of API production. Supply has periodically tightened due to environmental enforcement in Chinese chemical provinces. Market report

Frequently Asked Questions

Florfenicol is a broad-spectrum veterinary antibiotic used across three major production sectors. In aquaculture, it is the dominant antibiotic for bacterial disease in finfish (salmon, tilapia, catfish, carp) and shrimp — treating furunculosis, vibriosis, streptococcosis, columnaris, and edwardsiellosis via medicated feed at 10 mg/kg BW for 10 days. In cattle, it is a first-line injectable for bovine respiratory disease (BRD) at 20-40 mg/kg, with excellent lung tissue penetration. In swine, it treats respiratory disease caused by Actinobacillus pleuropneumoniae and Pasteurella multocida at 15 mg/kg IM every 48 hours. In poultry, it addresses colibacillosis and infectious coryza.
Chloramphenicol was banned from food-animal use in the US (1985), EU (1994), and most regulated markets due to a rare but fatal idiosyncratic aplastic anemia risk — approximately 1 in 25,000-40,000 patients — that was not dose-dependent and could not be predicted. Florfenicol was designed by Schering-Plough to solve two problems in one molecule: (1) Replace the p-nitro group of chloramphenicol (the moiety responsible for aplastic anemia) with a methylsulfonyl group, eliminating the human safety risk. (2) Replace the C-3 hydroxyl group with a fluorine atom, which blocks bacterial acetyltransferase — the primary resistance mechanism. The fluorine substitution is the structural key that makes florfenicol active against chloramphenicol-resistant strains while being safe for food animals with defined MRLs and withdrawal periods.
Three major differences: (1) Resistance profile: Florfenicol's C-3 fluorine atom blocks enzymatic acetylation — the primary amphenicol resistance mechanism — making it active against many thiamphenicol- and chloramphenicol-resistant strains. Thiamphenicol retains the C-3 hydroxyl and is susceptible to the same acetylation-based resistance. (2) Tissue distribution: The fluorine substitution increases lipid solubility, giving florfenicol superior lung penetration (lung-to-plasma ratio >1) and better intracellular penetration. This makes florfenicol more effective for respiratory disease. (3) Antimicrobial spectrum: Florfenicol shows lower MICs against key veterinary pathogens (Mannheimia haemolytica, Pasteurella multocida, Actinobacillus pleuropneumoniae) compared to thiamphenicol.
For aquaculture-grade florfenicol, five quality parameters require special attention: (1) Particle size distribution — finer, more uniform particles improve feed homogeneity and dissolution; specify your required D50 and D90 values. (2) Enantiomeric purity — florfenicol has two chiral centers; verify single-enantiomer purity by chiral HPLC. (3) Heavy metals — importing countries (EU, Japan, US) may enforce stricter limits for aquaculture products than for terrestrial livestock. (4) Thiamphenicol content — this is the key synthesis impurity indicator; should be ≤ 0.5%. (5) Microbial limits — verify TAMC/TYMC compliance with pharmacopoeia. KingWish provides particle size data and full impurity profiles on every aquaculture-grade batch CoA.
Standards: CVP, IN HOUSE  |  CAS: 73231-34-2  |  Quality data verified against pharmacopoeia monograph COA and MSDS available  |  DrugBank  |  July 2026

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