Enrofloxacin

Enrofloxacin is a synthetic fluoroquinolone antimicrobial agent utilized as an Active Pharmaceutical Ingredient (API) in veterinary formulation manufacturing. It targets bacterial DNA gyrase and topoisomerase IV, disrupting DNA replication and transcription in susceptible Gram-negative and Gram-positive pathogens.

International Nonproprietary Name (INN): Enrofloxacin
Chemical Name: 1-cyclopropyl-7-(4-ethylpiperazin-1-yl)-6-fluoro-4-oxo-quinoline-3-carboxylic acid
CAS Registry Number: 93106-60-6
Molecular Formula: C19H22FN3O3
Molecular Weight: 359.40 g/mol
Therapeutic Category: Broad-spectrum synthetic antibacterial (Veterinary API)

 

Product Specifications:

Compliance verification against pharmacopoeial monographs (USP/EP) for commercial batch release:

Test Parameter	Specification Standard	Test Method
Description	Pale yellow or almost white crystalline powder	Visual Inspection
Identification	Infrared absorption spectrophotometry (IR); HPLC retention time matches reference standard	USP / Ph. Eur.
Assay (Calculated on dried basis)	98.5% - 101.5%	HPLC
Melting Range	221 deg C - 226 deg C (with decomposition)	Capillary Method
Loss on Drying	<= 1.0% (dried under vacuum at 120 deg C)	Gravimetric Analysis
Residue on Ignition (Sulfated Ash)	<= 0.1%	Ph. Eur. 2.4.14
Heavy Metals	<= 20 ppm (<= 0.002%)	Colorimetric Method
Related Substances (Impurities)	Individual unspecified impurity: <= 0.10% Total impurities: <= 0.5%	Gradient HPLC
Residual Solvents	Meets ICH Q3C limits (Ethanol <= 0.5%, Dichloromethane <= 0.06%)	Headspace GC

 

Chemical & Physical Properties:

Appearance: Crystalline powder free of visible foreign matter.
Solubility: Very slightly soluble in water; slightly soluble in dimethylformamide and methanol; sparingly soluble in acetone and dichloromethane. Soluble in dilute aqueous solutions of alkali hydroxides and mineral acids.
PH (1% suspension in water): 7.2 - 8.5
Particle Size Distribution (d90): <= 75 um (micronized grade available for suspension formulations to optimize dissolution rate).
Polymorphism: Form A (thermodynamically stable crystalline modification confirmed via X-ray powder diffraction). 

 

Applications:

Enrofloxacin API is processed by veterinary pharmaceutical manufacturers into finished dosage forms for livestock and companion animals:

Poultry: Control and treatment of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum, colibacillosis (Escherichia coli), and fowl cholera (Pasteurella multocida). Administered via drinking water solutions or medicated feed premixes.

Swine: Treatment of porcine respiratory disease complex (PRDC), actinobacillus pleuropneumonia, and colibacillosis in piglets. Formulated as injectable solutions or oral powders.

Cattle & Small Ruminants: Management of bovine respiratory disease (BRD) and infectious pododermatitis (foot rot). Utilized in sterile injectable formulations.

Aquaculture: Treatment of bacterial infections in finfish caused by susceptible strains of Vibrio spp. and Aeromonas spp. (subject to regional veterinary approvals).

 

Pharmaceutical Manufacturing Relevance:

Formulation Compatibility: Compatible with standard excipients used in solid oral dosages, water-soluble powders, and aqueous-based injectable vehicles (utilizing appropriate co-solvents such as benzyl alcohol or propylene glycol).

Processability: Exhibits stable flow properties with a Hausner ratio of 1.15 - 1.28 and a Carr's index of 13% - 22%, minimizing bridging or segregation during direct compression or high-shear granulation.

Thermodynamic Stability: Retains chemical integrity under standard dry granulation and roller compaction temperatures up to 50 deg C.

 

Grade & Quality Requirements:

Pharmacopoeial Compliance: Manufactured in strict accordance with USP (United States Pharmacopeia) and Ph. Eur. (European Pharmacopoeia) monographs.

Regulatory Status: DMF (Drug Master File) available for regulatory review. Manufactured in facilities operating under current Good Manufacturing Practices (cGMP ICH Q7 guidelines).

TSE/BSE Statement: Certified free from Transmissible Spongiform Encephalopathies (TSE) and Bovine Spongiform Encephalopathy (BSE). No animal-derived raw materials are utilized in the synthesis pathway.

GMO Status: Product is free from Genetically Modified Organisms.

Residual Solvents: Complies fully with ICH Q3C guidelines; no Class 1 solvents are utilized or detected in the manufacturing process.

 

Quality Control:

Testing Protocol: Every production batch undergoes rigorous analytical testing prior to release. Testing is performed in an ISO/IEC 17025 accredited laboratory using validated HPLC, GC, and titration methods.

In-Process Controls (IPC): Monitored parameters include reaction temperature, catalyst residue filtration efficiency, crystallization kinetics, and centrifugation dryness.

Retention Samples: 3 times the commercial sample volume is retained for a minimum of 5 years past the retest date to ensure complete traceability.

Audit Trail: Complete electronic batch records (EBR) and raw material vendor qualification data are maintained for every lot, available for client quality audits upon execution of a confidentiality agreement (NDA).

 

Technical Documents:

Technical document packages are issued per commercial batch and provided upon order confirmation or audit request:

COA (Certificate of Analysis): Includes actual analytical values for assay, related substances, loss on drying, heavy metals, and residual solvents matched to the specific batch number.

SDS (Safety Data Sheet): Compliant with GHS (Globally Harmonized System) standards, detailing handling precautions, acute toxicity data, personal protective equipment (PPE) requirements, and spill response procedures.

TDS (Technical Data Sheet): Comprehensive summary of physical parameters, particle size distribution curves, recommended storage conditions, and shelf-life parameters.

 

Packaging & Storage:

Primary Packaging: Double-layer low-density polyethylene (LDPE) pharmaceutical-grade bags, heat-sealed under vacuum to eliminate moisture ingress.

Secondary Packaging: Rigid fiber drums or cardboard boxes fitted with tamper-evident seals.

Standard Net Weight: 25 kg / fiber drum.

Storage Conditions: Preserve in well-closed, tight, light-resistant containers below 25 deg C, protected from direct heat and moisture.

Shelf Life: 36 months from the date of manufacture when stored in unopened, original packaging under recommended conditions. (Retest date indicated on COA).

 

Supply & Procurement:

MOQ (Minimum Order Quantity): 25 kg (1 standard drum).

Sample Policy: 100 g analytical samples available for laboratory evaluation and method validation. Courier shipping costs apply unless freight-collect account details are provided.

Lead Time:

Spot orders (ex-stock): Dispatch within 5 to 7 business days following payment clearance.

Scheduled orders (annual contract): Shipped according to agreed quarterly delivery schedules.

Bulk Supply Capacity: Annual production capacity of 120 metric tons, supporting multi-ton bulk shipments with dedicated container allocation.

 

OEM / Custom Specification:

Particle Size Customization: Micronization services available to adjust particle size distribution (d90 < 20 um) for specific suspension or injectable manufacturing requirements.

Custom Packaging: Alternative packaging formats (such as 5 kg foil bags or customized drum labeling) can be arranged for contract manufacturing operations requiring specific plant entry protocols.

 

 

Request a Quote:

Submit your procurement specifications, required volume, and destination port to receive a commercial quotation including FOB/CIF pricing and batch-specific documentation previews.
Required Information for Quotation:
Annual volume requirement or spot order quantity
Destination port / Delivery location
Target delivery schedule
Specific documentation requirements (e.g., specific pharmacopoeia edition)

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