| HS Code | 551617 |
| Generic Name | Cefepime (INN) |
| Brand Name Example | Maxipime |
| Grade | Veterinary grade API |
| Chemical Class | Fourth-generation cephalosporin beta-lactam antibiotic |
| Molecular Formula | C19H24N6O5S2 |
| Molecular Weight | 480.56 g/mol |
| Cas Number | 88040-23-7 |
| Physical Description | White to pale yellow crystalline hygroscopic powder |
| Solubility | Freely soluble in water; sparingly soluble in methanol; practically insoluble in most non-polar organic solvents |
| Shelf Life | Typically 24 months when stored unopened under recommended conditions |
| Assay Purity | Highest purity typically >=98.0% on dried basis by HPLC |
| Intended Dosage Forms | Tablets, capsules, powders, granules, premix, and sterile injections or solutions after appropriate veterinary pharmaceutical formulation |
| Mechanism Of Action | Inhibits bacterial cell-wall synthesis by binding to penicillin-binding proteins, causing bacterial cell lysis |
| Antimicrobial Profile | Broad-spectrum activity against many Gram-positive and Gram-negative bacteria including Pseudomonas species; stable to hydrolysis by many beta-lactamases |
As an accredited Cefepime (Maxipime) Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Sealed aluminum foil pouches with double polybags, 1 kg net weight, moisture-proof, labeled for veterinary API use. |
| Container Loading (20′ FCL) | 20′ FCL shipment of Cefepime veterinary-grade API, securely packed in sealed drums, palletized, labeled, and container-loaded for safe transit. |
| Shipping | Shipments of Cefepime (Maxipime) Veterinary Grade API are dispatched in sealed, moisture-proof containers, protected from light and extreme temperatures. Handling follows pharmaceutical safety protocols, with secure, labeled packaging to prevent contamination. All transports comply with applicable veterinary drug regulations, ensuring product integrity and traceability throughout delivery. |
| Storage | Store Cefepime Veterinary Grade API in its original, tightly sealed container, in a cool, dry, well-ventilated area. Protect from light, moisture, and heat; do not store above 25°C. Avoid freezing. Keep away from oxidizing agents. Once opened, use promptly and ensure container is resealed securely. Discard unused material per local regulations. |
| Shelf Life | Shelf Life: 24 months from manufacture date when stored unopened in original container, below 25°C, protected from light and moisture. |
Cefepime hydrochloride, the active moiety in Maxipime, is filled into Type I borosilicate glass vials as a sterile crystalline powder combined with L-arginine at 725 mg per 1 g cefepime to buffer the reconstituted solution to pH 4.0–6.0 at a nominal concentration of 100 mg/mL. A 1 g vial is reconstituted with 10 mL Sterile Water for Injection USP; a 0.5 g vial requires 5 mL, and a 2 g vial requires 20 mL. The industrial downstream process is aseptic powder fill-finish under Grade A unidirectional airflow within restricted access barrier systems, because terminal steam sterilization is excluded by beta-lactam ring thermolability. Gravimetric filling heads with ±0.5% in-process mass verification are specified for batch uniformity; filled vials are subjected to vacuum decay leak testing and package integrity evaluation under USP <1207>. Compliance is controlled against USP <71> Sterility Tests, USP <85> Bacterial Endotoxins Test, the current USP monograph for Cefepime for Injection, and EU GMP Annex 1:2022 viable and non-viable particle thresholds for aseptic processing. The resulting article of commerce is sterile powder for injection in 0.5 g, 1 g, and 2 g strengths, intended for reconstitution to intravenous or intramuscular solutions in non-food animal hospitals. Equipment changeover after beta-lactam filling requires validated alkaline hydrolysis of residues before routine cleaning, with HPLC swab analysis used for release of contact surfaces.
In 24-hour equine critical-care units, reconstituted cefepime at 100 mg/mL is diluted to final concentrations of 5–20 mg/mL in 0.9% Sodium Chloride Injection USP or Lactated Ringer's Injection USP for intravenous infusion. Admixture preparation occurs in ISO Class 5 laminar-airflow workstations compliant with USP <797>; prepared low-risk compounded sterile preparations are assigned a 48-hour beyond-use date at 20–25 °C or 14 days at 2–8 °C, while the innovator label supports 24-hour room-temperature stability and 7-day refrigerated stability for cefepime concentrations between 1 mg/mL and 40 mg/mL. The final hospital-level presentation is a sterile IV admixture bag of 50 mL, 100 mL, or 250 mL, delivered through volumetric infusion pumps calibrated to ±5% flow accuracy; syringe pumps are used for low-volume equine neonatal protocols. Handling of the admixture avoids aminoglycoside co-infusion in the same line unless separated by a compatible flush, because beta-lactam–aminoglycoside inactivation in high-pH or prolonged-contact conditions is documented in human critical-care pharmacy stability studies; published veterinary-specific incompatibility data remain limited. The reconstituted solution is not filtered downstream because it is already sterile, but a 0.2 µm low-protein-binding filter may be used only if particulate contamination is suspected. The admixture is protected from light and observed for precipitation or color change from pale yellow to amber; any visible precipitation triggers discard under USP <797> physical compatibility criteria. For non-food animal species, extra-label use of this fourth-generation cephalosporin falls under FDA AMDUCA 21 CFR 530, which requires a valid veterinary-client-patient relationship; extra-label cephalosporin use in cattle, swine, chickens, and turkeys is prohibited under 21 CFR 530.41.
| Diluent | Acceptable cefepime concentration range | Beyond-use at 20–25 °C | Beyond-use at 2–8 °C |
|---|---|---|---|
| 0.9% Sodium Chloride Injection USP | 1–40 mg/mL | 24 h | 7 days |
| 5% Dextrose Injection USP | 1–40 mg/mL | 24 h | 7 days |
| Lactated Ringer's Injection USP | 1–40 mg/mL | 24 h | 7 days |
Cefepime is not supported as an oral solid dosage form because the molecule exhibits high aqueous solubility but negligible oral bioavailability in monogastric species; the addition ratio for a tablet or capsule intended for systemic therapy is therefore 0 mg per unit in any defensible formulation. The relevant compliance filters are the absence of a USP veterinary monograph for cefepime oral tablets, absence of an approved veterinary oral product in the FDA Green Book, and the permeability classification in biopharmaceutics data used for bioequivalence waivers. A wet-granulation process with aqueous binder would expose the beta-lactam ring to hydrolytic degradation before compression; dry granulation or direct compression would not correct the permeability limitation. Dissolution testing in 0.1 N hydrochloric acid per USP <711> cannot serve as a surrogate for absorption because the molecule is degraded in gastric fluid rather than absorbed across the jejunal epithelium. Enteric-coated tablets or capsules would shift release to distal intestinal segments, but published permeability data for cefepime indicate that the fraction absorbed would remain below the threshold required for therapeutic plasma concentrations. No oral tablet or capsule terminal product is generated from this API; only parenteral and compounded non-enteric preparations are recognized as valid downstream outputs. The regulatory signal is equally restrictive: FDA-CVM has not established a tolerance for cefepime residues in food-producing species, and oral extra-label administration would not be allowed under 21 CFR 530.41 for cattle, swine, chickens, or turkeys. Published data for cefepime oral pharmacokinetics in dogs and cats are limited; no companion-animal tablet or capsule master formula can be validated from existing public monographs.
Granule and premix development for feed or drinking water administration in food-producing animals is stopped at the regulatory threshold because 21 CFR 530.41 prohibits all extra-label uses of cephalosporin drugs in cattle, swine, chickens, and turkeys, and no cefepime feed-additive or veterinary feed directive approval exists in the FDA Green Book. The addition ratio in any finished feed or premix is therefore 0 mg/kg for food-producing species; no terminal premix, granule, or medicated drinking water product can be legally manufactured for those markets. For non-food animal compounding, bulk API powder may be subdivided only for injectable or sterile solution preparation under USP <797>, not for oral granules. The downstream production process that would be required for a beta-lactam premix—dry blending in horizontal ribbon mixers or double-cone tumble mixers, followed by moisture-barrier polyethylene-lined feed bags—cannot be validated for cefepime because the regulatory prohibition removes the legal basis for line commissioning. Cleaning validation for beta-lactam residues remains mandatory even in non-food animal compounding facilities; equipment contact surfaces are swab-sampled and analyzed by HPLC with a limit of detection no higher than 0.1 µg/cm², and alkaline deactivation is used before routine cleaning. No licensed feed-additive presentation exists for this API; published data for cefepime stability in pelleted feed matrices are limited, which reinforces the absence of a real downstream premix route.
When a veterinary hospital or sterile compounding pharmacy receives bulk cefepime hydrochloride, the downstream process is repackaging into single-dose glass vials under aseptic conditions rather than formulation with additional excipients. The addition ratio is unchanged from the incoming API: 1.0 g or 2.0 g cefepime activity per vial, with no diluent added at the repackaging stage. The operation is performed in an ISO Class 5 laminar-airflow workstation within an ISO Class 7 cleanroom, following USP <797> and ISO 14644-1:2015 airborne particulate limits. A five-place analytical balance with ±0.01 g readability is used for gravimetric dispensing; volumetric scoops are excluded because bulk powder density varies with particle size and moisture content. The repackaged terminal presentation is a patient-ready sterile powder vial for reconstitution to 100 mg/mL in non-food animal patients. Each vial is sealed with fluoropolymer-laminated stoppers and aluminum flip-off seals, then leak-tested by vacuum decay per USP <1207> or equivalent package integrity evaluation. The repackaging batch size is limited to the quantity that can be dispensed within the assigned beyond-use date of the incoming bulk API, and the receiving pharmacy retains the supplier certificate of analysis showing compliance with the USP monograph for Cefepime for Injection. Environmental monitoring includes settle plates, contact plates, and active air sampling in the critical zone; any excursion above action levels for Grade A/ISO 5 conditions triggers batch quarantine and re-testing under USP <797>. The operational boundary in this process is moisture control: bulk powder handling above 60% relative humidity is performed with dry air purge to reduce moisture uptake, because cefepime hydrochloride is hygroscopic and hydrolysis can shift reconstituted solution pH. Incompatibility with strong oxidizing agents and strong alkaline solutions is documented; decontamination of beta-lactam residues on balances and containment equipment uses alkaline hydrolysis followed by rinsing with Purified Water USP, with the waste stream segregated from routine pharmaceutical wastewater.
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Cefepime (Maxipime) veterinary grade API is supplied as cefepime hydrochloride monohydrate, a crystalline beta-lactam powder intended for downstream processing into tablets, injections, capsules, powders, granules, premix, and solutions. The substance is a 4th-generation cephalosporin bearing an aminothiazolyl methoxyimino side chain at C-7 and a 1-methylpyrrolidinium substituent at C-3; this quaternary ammonium group gives the molecule a zwitterionic character and influences aqueous solubility, osmolality, and renal clearance. The anhydrous base is identified by CAS 88040-23-7, and the hydrochloride monohydrate salt by CAS 123171-59-5. In compendial nomenclature, the compound is designated 7-[(2Z)-2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido]-3-[(1-methylpyrrolidin-1-ium-1-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monohydrochloride monohydrate. Because cefepime is not approved as a veterinary drug in several major jurisdictions, the material is normally distributed as a pharmaceutical intermediate for licensed compounding, research, or registered veterinary medicinal product manufacture under 21 CFR 210/211 or equivalent local good manufacturing practice. The term “veterinary grade” therefore refers to a route-specific control strategy rather than a separate molecular entity.
Release of cefepime hydrochloride for veterinary formulations generally follows the USP Cefepime Hydrochloride monograph and, for parenteral-grade material, USP <85>, USP <71>, and USP <791>. The absence of a globally harmonized veterinary-specific monograph means that the human API specification is adapted to each dosage form; limits for injectable material are stricter than those for oral powders and feed premixes. Table 1 summarizes commonly applied controls. These values are compendial directions rather than batch-specific guarantees; a vendor certificate of analysis should be verified by independent HPLC assay using a qualified reference standard.
| Parameter | Control basis | Test method/standard |
|---|---|---|
| Appearance | White to off-white crystalline powder | Visual inspection |
| Identification | HPLC retention time and IR spectrum | USP <197>, USP <621> |
| Assay, anhydrous and solvent-free basis | 98.0%–102.0% | HPLC |
| Water content | 3.0%–4.5% | Karl Fischer, USP <921> |
| pH of 1% solution | 1.8–2.4 | USP <791> |
| Related substances | Any single specified impurity not more than 0.5%; total not more than 2.0% | HPLC |
| Bacterial endotoxins, parenteral grade | <0.10 EU/mg | USP <85> |
| Sterility | Sterile when so labeled | USP <71> |
| Residue on ignition | <0.1% | USP <281> |
| Elemental impurities | Route-specific limits | USP <232> |
Assay is run against cefepime hydrochloride reference standard using a C18 column with phosphate buffer–acetonitrile mobile phase; system suitability requires a resolution factor not less than 2.0 between cefepime and its principal degradation product, per USP <621>. Duplicate injection precision is typically not more than 1.0% RSD. For feed premixes, a reduced assay window may be accepted if blend homogeneity is statistically controlled, but injectable projects should not relax the 98.0%–102.0% interval without formal stability and bioequivalence justification.
Manufacture of injectable cefepime solutions begins with dissolution of the monohydrate in water for injection at a concentration that depends on the final dosage form. The pH is adjusted to 4.0–6.0 using sodium hydroxide or hydrochloric acid; outside this region the beta-lactam ring undergoes hydrolysis at an accelerated rate. The solution is aseptically filtered through a 0.22 µm PVDF or PES membrane and filled into sterilized vials. Jacketed 316L stainless steel holding tanks maintained at 2–8°C are used before filtration, and total processing time from dissolution to filling is controlled; degradation above 25°C accelerates rapidly under acidic or alkaline conditions. For lyophilized products, the filled solution is frozen to shelf temperatures below -40°C, followed by primary drying at -20°C to -10°C under vacuum and secondary drying at 20–25°C. Collapse during primary drying occurs if the product temperature exceeds the collapse temperature; formulations with bulking agents such as mannitol or glycine are used to maintain a robust cake. Cefepime is incompatible with aminoglycosides in parenteral admixture; the two classes must not be mixed in one container. Sterile filtration compatibility should be verified by filter integrity testing and extractable data. Published data for cefepime in specific veterinary infusion bag configurations is limited; therefore visual clarity, pH, and assay should be checked at 0, 1, 2, and 4 h before a new admixture protocol is released.
Dry processing of cefepime monohydrate requires low relative humidity and careful particle size control. The monohydrate can exhibit electrostatic charging when relative humidity falls below 30% RH; this behavior produces non-uniform distribution in direct compression blends. Delumping through a 500 µm sieve is usually the first step. Because cefepime is highly water-soluble, aqueous wet granulation is generally avoided unless the granulating fluid is non-aqueous or the drying protocol is short and tightly controlled. Dry granulation by roller compaction is used for tablets; roll force, screen size, and compaction speed are set by design of experiments because published data for cefepime-specific granulation is limited. Blend uniformity is assessed by sampling at 10 locations with a 3–5 g sample mass; acceptance is 90.0%–110.0% label claim with relative standard deviation not more than 5.0%. In medicated premixes, the active ingredient is first geometrically diluted with lactose monohydrate or corn starch. Trace minerals and acidic carriers should be separated because cefepime is not stable below pH 3 and degrades in the presence of strong oxidizing agents. Capsule filling requires dried granulations with loss on drying not more than 4.5%; higher moisture can cause sticky powder flow and capsule shell brittleness.
Tablet and capsule products are evaluated by USP <701> disintegration and USP <711> dissolution rather than only assay. The intrinsic solubility of cefepime HCl produces rapid release in 0.1 M hydrochloric acid, often exceeding 85% dissolved in 30 min. However, tablet gelation can occur if high-swelling disintegrants such as sodium starch glycolate are used above 8%; crospovidone at 2%–5% or croscarmellose sodium at 1%–3% is preferred. Direct compression is usually not practical because the powder has poor flow; roller compacted granules with magnesium stearate at 0.5% provide sufficient flow and lubrication. Film coating with hydroxypropylmethylcellulose may be applied, but aqueous coating pans should keep tablet bed temperature below 40°C to minimize hydrolytic loss. For oral solutions, the API is dissolved in a buffered vehicle at pH 4.0–6.0; because aqueous stability is limited, refrigeration at 2–8°C and a beyond-use date not exceeding 7 days are typical for compounded oral liquids unless long-term stability data support a longer period. ICH Q1A(R2) stress testing should be performed to establish route-specific shelf life.
Compared with ceftiofur sodium, cefepime has a different salt form and solubility profile. Ceftiofur sodium is a third-generation cephalosporin approved in cattle, swine, sheep, goats, and poultry; its soluble powder for injection is often reconstituted into an oil-based suspension. Cefepime is not an oil suspension; it is a water-soluble hydrochloride salt intended for aqueous injection. Direct substitution in the same administration syringe is therefore not valid. Cefquinome sulfate is a veterinary fourth-generation cephalosporin with a similar beta-lactamase stability profile, but cefepime has stronger antipseudomonal activity under human clinical breakpoints; whether this activity translates to veterinary infections requires species-specific susceptibility testing. The structural C-3 1-methylpyrrolidinium substituent of cefepime changes outer membrane penetration in Gram-negative organisms and reduces affinity for certain AmpC beta-lactamases compared with third-generation ceftiofur. No harmonized veterinary population pharmacokinetic model for cefepime in horses, dogs, or cats exists globally, and published data for food-producing species are sparse. Dose conversion from ceftiofur cannot be made by simple molar equivalence; a veterinarian must establish the dose and withdrawal status under national extra-label use provisions. In the United States, extra-label use of cephalosporins in food-producing animals is restricted under 21 CFR 530.41. The material should be stored in airtight containers at 20–25°C with a desiccant; excursions above 30°C or relative humidity above 60% can initiate hydrolysis and caking.
The regulatory documentation package for veterinary cefepime is route-specific. Table 2 lists the principal standards and reference points used in release and stability governance.
| Standard/regulation | Application | Route-specific control |
|---|---|---|
| 21 CFR 210/211 | Current good manufacturing practice | Batch records, laboratory records, cleaning |
| USP <85> | Bacterial endotoxins | <0.10 EU/mg for injectable grade |
| USP <71> | Sterility | Membrane filtration and direct inoculation |
| USP <232> | Elemental impurities | Arsenic, cadmium, lead, mercury limits by route |
| ICH Q1A(R2) | Stability testing | Long-term 25°C/60% RH; accelerated 40°C/75% RH |
| 21 CFR 530.41 | Extra-label use in food-producing animals | Prohibited uses and residue considerations |
For sterile injectable release, container closure integrity and bacterial endotoxin testing are mandatory; for oral powders and feed premixes, blend uniformity and moisture controls replace sterility as the critical quality attributes. The physical form remains the same monohydrate salt, but the control strategy must shift from parenteral aseptic assurance to dry-state chemical stability and feed homogeneity. Compounded veterinary formulations containing cefepime require species-specific stability and residue data; in the absence of published data for a given target species, a pilot study using a validated HPLC method is the minimum acceptable engineering control before line scale-up.
