Pure Florfenicol Powder

Premium Pure Florfenicol Powder for Veterinary Applications | High-Purity Antibiotic Solution from Certified Manufacturer

Shaanxi Hongda Phytochemistry Co., Ltd. stands as a trusted manufacturer and supplier of pharmaceutical-grade Pure Florfenicol Powder, delivering consistent 98% purity backed by rigorous quality assurance protocols. We are a recognised manufacturer with cGMP, FSSC22000, ISO9001 and ISO22000. With more than 20 years experience in extraction and advanced purification workshops of 100,000 level, we guarantee that each batch of the product fulfils the international pharmaceutical standards. Our best-in-class testing infrastructure, including HPLC and GC systems, with more than 20 PhD-level researchers, ensures minimal levels of residues, controlled particle distribution and traceable documentation, directly addressing your formulation stability requirements, and regulatory compliance needs in the veterinary medicine markets.

Product Description

The compound is a broad-spectrum fluorinated thiamphenicol analogue developed for animal antibiotic use. It is a white to off-white crystalline powder with increased bacteriostatic action against Gram-positive and Gram-negative infections by interfering with bacterial protein synthesis at the ribosome level. Florfenicol is chosen over chloramphenicol for treatment procedures in livestock and aquaculture because it does not have the same danger of inducing aplastic anaemia in animals, an important factor in developing products with significant safety margins and withdrawal periods.

Pure Florfenicol Powder Advantages

Molecular Stability: The introduction of fluorine at C3 increases the chemical stability in acidic stomach conditions, decreasing the degradation rates by 40%, relative to thiamphenicol, suggesting increased bioavailability in oral formulations.

Regulatory Compliance: Our manufacturing process is GMP+ and FAMI-QS compliant for feed additive manufacture, and we have comprehensive traceability paperwork to support VICH guideline submissions for new veterinary medication applications.

Low Residue Profile: Faster clearance kinetics result in reduced withdrawal times for meat and milk production, answering key market access needs for export-oriented animal operations.

Batch Consistency: The coefficient of variation for active content is maintained at less than 1.5% across manufacturing batches, guaranteeing accurate dosage formulation and minimising reformulation costs throughout scale-up stages.

Application of Pure Florfenicol Powder

Aquaculture Therapeutics: Used widely in medicated feed premixes at 10-20 mg/kg for the treatment of bacterial septicaemia in fish and prawns. Water-stable formulations have been developed to limit environmental leaching and to preserve therapeutic concentrations.

Swine Respiratory Disease: It is formulated as water-soluble powders or injectable solutions to combat Actinobacillus pleuropneumoniae and Pasteurella multocida infections, using florfenicol’s outstanding penetration of lung tissue.

Bovine Respiratory Complex: Long acting injectable depot formulations are used to maintain plasma concentrations above MIC90 levels for 72-96 hours, minimising the labour costs of recurrent treatment methods.

Poultry Applications: Pure Florfenicol Powder may be used in drinking water medicines for the prevention of Escherichia coli and Salmonella infections in broilers with dosing flexibility provided by the quick dissolving profile of the powder in automated medication systems.

Manufacturing Process

Step 1 – Raw Material Synthesis: The chemical synthesis starts with the thiamphenicol base that is fluorinated under regulated temperature and pressure conditions. Result: High purity intermediate verified by NMR spectroscopy.

Step 2 – Crystallisation Purification The crude product is then purified in many stages of crystallisation using pharmaceutical grade solvents in our 100,000 level clean rooms. Designed crystal shape for homogeneous particles dispersion and better flowability.

Step 3 – Drying and Milling: The material is vacuum dried under 50°C in an effort to maintain thermally sensitive bonds. It is then jet milled to the desired particle specs. Result: Free-flowing powder with D90 <75 μm for direct compression or encapsulation.

Step 4 – Quality Verification: All batches are tested using a 23 point testing process including HPLC assay, residual solvent analysis and microbiological limits testing before they are released. Outcome: COA paperwork with complete traceability codes for regulatory filings.

Third Party Test Report

Pesticide Residue Analysis (Multi-residue Screening) Our product is tested by SGS labs and found to have non-detectable levels of more than 500 pesticide compounds as per EU regulatory criteria; hence fulfilling the need for export to regulated markets such as North America and Europe.

Heavy Metal Verification: Testing confirmed by Eurofins confirms lead (Pb) level is less than 0.5 ppm, arsenic (As) is less than 0.3 ppm, and mercury (Hg) is below detection limit, fulfilling USP <232> criteria for heavy metals for pharmaceutical-grade raw materials.

Microbiological safety : Total plate count continuously <1000 CFU/g , yeast and mould <100 CFU/g , and Salmonella and E . coli are absent in 25g samples . Sterility is confirmed , representing sterility appropriate for direct compounding into completed dosage forms .

Why Choose Us

Shaanxi Hongda’s 20,000 square metre site has 10+ specialised manufacturing lines with an annual capacity surpassing 3,000 tonnes, providing the assured supply continuity even during high seasonal demand. We have an ISO-certified quality management system with automated batch tracking in six specialised storage zones that provide the best conditions to guarantee product integrity from synthesis to delivery. What we provide is not just raw materials, but extensive technical relationships that include over 150 qualified technicians and professor-led research teams with several national patent innovations. Our strategic position offers affordable logistics to European, North American and Asian markets with delivery timetables reliably achieving 3-7 day promises. Our multi-certification portfolio (Halal, Kosher, BRC, FDA) removes market access restrictions for your final goods

OEM/ODM Service

Custom Formulation Development Our R&D team creates customised mixes of florfenicol with synergistic vitamins or immune modulators and utilises particle engineering or lipid encapsulation methods for optimum bioavailability for your target species.

Flexible Packaging Solutions: We can handle bulk orders ranging from 100kg drums to bespoke retail packaging with your logo, incorporating moisture-barrier foil pouches, child-resistant containers or veterinary clinic specific unit dosages to improve market distinctiveness.

Regulatory Documentation Support: Comprehensive dossier preparation services include stability studies as per ICH recommendations, comparative bioavailability data and environmental safety assessments necessary for new veterinary medical product registrations in numerous countries.

Analytical Method Transfer:  We provide complete validation packages for your in-house QC procedures, including HPLC protocols, reference standards, and troubleshooting help, to ensure a smooth technology transfer to your quality labs.

FAQ

Q: How does pharmaceutical grade florfenicol powder vary from feed grade florfenicol powder?

A: Pharmaceutical-grade has stronger limitations for residual solvents (<50 ppm vs. <500 ppm), lower limits for endotoxins (<0.5 EU/mg), and approved sterility testing. Feed-grade is more economical for large-volume premix applications.

Q: How should bulk the product be stored to prevent degradation?

A: Store in sealed fibre barrels at 25°C and relative humidity below 60% and away from direct sunshine. Accelerated stability experiments show >98% assay retention for 24 months with proper storage of material.

Q: Are there any florfenicol formulations with improved water solubility?

A: Yes. Our ODM services are capable of generating spray-dried powder formulations with hydrophilic carriers or cyclodextrin complexes that are completely soluble in ambient water within 2 minutes.

Q: What documentation supports export to EU markets?

A：We provide complete regulatory packages including EU GMP compliance certificates, residue depletion studies meeting EMA guidelines, and environmental risk assessments per VICH GL6 requirements.

Q: What is the typical lead time for customized specifications?

A：Standard purity adjustments or particle size modifications require 15-20 days including validation testing, while novel formulations with stability studies extend to 45-60 days depending on complexity.

Contact Us

Ready to secure a reliable supply of premium Pure Florfenicol Powder for your veterinary formulations? Contact Us today at duke@hongdaherb.com  to request detailed specifications, sample shipments, or discuss custom development partnerships.