Meta description: Enrofloxacin base API is a core veterinary fluoroquinolone for oral, injectable, and aquaculture formulations. Compare specifications, salt vs base forms, light-stability handling, and sourcing strategy for B2B buyers.

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Why Enrofloxacin Base Remains a Core Veterinary API

Enrofloxacin base sits in a small group of veterinary antibiotic APIs that have stayed commercially relevant for decades. First introduced for veterinary use in the late 1980s, the molecule is now used by veterinary medicinal product (VMP) manufacturers across companion-animal, livestock, and aquaculture formulations — oral solutions, injectables, premixes, tablets, and medicated feed.

For B2B buyers, enrofloxacin base is the most flexible starting point because the same lot of base API can be converted into the hydrochloride, lactate, or other salts downstream, depending on the target dosage form and target species. This makes it the preferred procurement form for VMP manufacturers that operate multiple product formats.

At the same time, enrofloxacin is one of the more technically demanding fluoroquinolone APIs to handle. Light-induced degradation, tight impurity control, and a fragmented regional regulatory landscape all shape how the API should be specified, packaged, and shipped. This guide walks through the technical and sourcing considerations a B2B buyer needs to get right.

Enrofloxacin Base API: Technical Profile

For buyers qualifying a new supplier, the following specifications are standard industry reference points.

Specifications above are typical industry reference ranges. Always confirm against the supplier's CoA and the monograph for your target market (USP, EP, ChP, or in-house standard).

Salt vs Base: Choosing the Right Form

A common source of confusion at procurement time is whether to buy enrofloxacin base or one of its salts. The right answer depends on the target dosage form, target species, and the regulatory dossier you intend to file.

Enrofloxacin base. The neutral form is the most flexible starting material. It is the preferred choice when:- You operate a multi-product VMP portfolio and want to control salt conversion in-house.- Your target formulation requires a specific counterion (e.g., lactate for a soluble powder, HCl for an injectable solution).- You need maximum purity and tight impurity control for a generic dossier.

Enrofloxacin hydrochloride. The HCl salt is the most widely used form for water-soluble oral solutions and injectables. If your formulation is a single-product, water-soluble dosage, buying HCl directly can skip a conversion step.

Enrofloxacin lactate and other salts. Lactate is common in some markets for certain solution formulations. Sodium and mesylate variants appear less frequently but exist for specific formulation targets.

For B2B buyers running multi-format VMP lines, the base form is usually the most economical choice long term, even if it requires a small in-house salt-conversion capability.

Stability and Handling: The Light-Degradation Problem

Enrofloxacin is one of the more light-sensitive APIs in the fluoroquinolone class. Photodegradation produces a number of known impurities, some of which are individually specified in pharmacopeial monographs. For a B2B buyer, light-stability is not a theoretical concern — it directly affects shelf life, retest intervals, and how the API must be packaged, stored, and shipped.

Packaging. Qualified enrofloxacin base API is supplied in opaque or amber inner liners, typically inside a sealed fiber drum. The inner liner should be opaque (not transparent PE), and the drum should protect the product from light during transit and warehouse storage.

Storage conditions. Keep below 25 °C, in a dry environment, away from direct sunlight. Avoid storage near UV sources. A temperature-monitored warehouse is recommended for inventory above 30 days.

Shipping. For intercontinental shipments, ask your supplier about light-protective outer packaging and validated lane qualification. For repackaging at your site, validate the repackaging operation under amber-light or controlled lighting to avoid re-introducing photodegradation impurities.

Retest interval. Industry-standard retest intervals for enrofloxacin base range from 24 to 36 months when stored under recommended conditions. Always confirm retest interval against your specific batch's stability data.

Formulation Compatibility

Enrofloxacin base is well characterized for the following formulation types:

For B2B buyers developing a new VMP dossier, a common mistake is to assume the impurity and degradation profile of the finished product will mirror the base API. In practice, excipient interactions and process conditions during granulation, drying, or sterilization can introduce additional impurities. Confirm with your supplier which impurities are likely to carry over into your specific dosage form.

Global Regulatory Landscape

The regulatory status of enrofloxacin varies significantly by region, and B2B buyers should always reconfirm current status before locking in supply for a specific market.

● **European Union.** Fluoroquinolones are classified as critically important antimicrobials. Enrofloxacin is restricted in poultry and limited in indications across many EU member states. New VMP dossiers targeting the EU should be reviewed by a regulatory consultant familiar with current EMA and CVMP positions.

● **United States.** FDA-approved VMPs exist for bovine, swine, and some companion-animal uses. Withdrawal periods and prescription-status rules vary by indication and formulation.

● **China and Asia-Pacific.** China, Vietnam, Indonesia, Thailand, and the Philippines remain large markets for enrofloxacin VMPs in livestock and aquaculture. Domestic pharmacopeial standards apply, and CDE-equivalent filings are required for new generic VMPs.

● **Latin America and MENA.** Significant VMP manufacturing hubs exist, with local regulatory frameworks that often align with international pharmacopeias.

For multi-market VMP manufacturers, the simplest path is usually to source base API at a single quality standard (USP, EP, or ChP) and document the regional variations in the local dossier.

Supply Landscape

Enrofloxacin base API is supplied by a mix of Chinese, Indian, and European manufacturers, with China holding the largest share of global capacity. Mature manufacturing processes mean that qualified supply is generally available, but the B2B buyer should still qualify each supplier against documented quality standards, not just price.

Typical lead times. 4–8 weeks for standard pack sizes (1–25 kg) from qualified manufacturers. Larger commercial quantities may require 10–14 weeks.

Common quality issues. Photodegradation impurities, residual solvents, and inconsistent particle size are the three issues that show up most often in supplier audits. Always ask for the supplier's photostability data, residual solvent profile, and laser-diffraction particle-size report.

MOQ and pricing dynamics. MOQs typically range from 1 kg for R&D use to 25 kg or 50 kg for commercial supply. Pricing has trended down over the past decade as additional generic capacity came online, but light-stability requirements and impurity specifications keep a meaningful quality premium for higher-purity grades.

Sourcing Checklist for B2B Buyers

A practical 6-step qualification workflow for enrofloxacin base API:

1. Confirm target pharmacopeia. USP, EP, ChP, or in-house standard. Verify the supplier's monograph alignment.

2. Request a sample CoA and full analytical package. Look for HPLC purity, related substances at ICH Q3A reporting thresholds, residual solvents per ICH Q3C, heavy metals, loss on drying, and microbial limits.

3. Verify light-stability data. Ask for forced-degradation and photostability studies. Confirm the inner liner is opaque and the outer packaging protects against light during transit.

4. Audit manufacturing practices. On-site or remote audit covering GMP compliance, change-control history, impurity-tracking systems, and validated analytical methods.

5. Confirm documentation package. CoA, DMF/CEP/CDE reference letters where applicable, residual solvent profiles, endotoxin (or microbial limits, as relevant), and stability data covering the full retest interval.

6. Negotiate packaging and shipping. Validated cold-chain or ambient shipping with temperature loggers, GDP-compliant documentation, and clear amber-light protection throughout.

Frequently Asked Questions (FAQ)

What is the CAS number for enrofloxacin base?Enrofloxacin base has CAS Number 93106-60-6.

What purity level is typical for enrofloxacin base API?Industry standard purity is ≥ 99.0% by HPLC, with total impurities typically controlled to ≤ 1.0%. Final specifications should be aligned with your formulation's target pharmacopeia.

What is the difference between enrofloxacin base and enrofloxacin HCl?Base is the neutral form; HCl is the hydrochloride salt. Base is the most flexible starting material for manufacturers that produce multiple dosage forms. HCl is preferred for water-soluble formulations where conversion in-house is not practical.

Is enrofloxacin base light-sensitive?Yes. Enrofloxacin is photolabile and degrades under UV and strong visible light. Qualified suppliers use opaque liners, amber packaging, and validated photostability data.

What packaging sizes are available?Standard pack sizes range from 1 kg for R&D use to 5 kg and 25 kg fiber drums for commercial supply. Custom packaging is typically available on request.

What storage conditions are required?Below 25 °C, in a dry environment, protected from light, in a sealed container. Retest intervals of 24–36 months are typical when stored under recommended conditions.

What regulatory considerations apply for the EU market?Fluoroquinolones including enrofloxacin are restricted in poultry across many EU member states. New VMP dossiers targeting the EU should be reviewed by a regulatory consultant familiar with current EMA and CVMP positions.

Can enrofloxacin base be used in aquaculture formulations?Yes, enrofloxacin is used in aquaculture VMPs in several Asian markets, typically as a medicated-feed premix. Local regulatory frameworks vary by country.

About Our Enrofloxacin Base API Supply

We supply enrofloxacin base and selected salts for veterinary medicinal product manufacturing, premix formulations, and aquaculture applications. Documentation packages are aligned to USP, EP, and ChP requirements, and our manufacturing partners operate GMP-capable facilities with full analytical support and validated packaging for light-sensitive APIs.

For technical data sheets, batch-specific CoA samples, DMF/CEP/CDE documentation, or a qualified-supplier audit, please contact our B2B team.

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