| HS Code | 401419 |
| Productname | Cefovecin Veterinary Grade API (as cefovecin sodium) |
| Chemicalname | (6R,7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-(methoxyimino)acetamido]-3-[[[(2-methyl-5-oxo-5,6-dihydro-4H-cyclopenta[b]thiophen-3-yl)carbonyl]amino]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt |
| Casnumber | 234096-34-7 |
| Molecularformula | C17H18N5NaO6S3 |
| Molecularweight | 507.54 g/mol |
| Appearance | White to off-white crystalline powder |
| Solubility | Freely soluble in water; sparingly soluble in ethanol; practically insoluble in chloroform and lipid solvents |
| Shelflife | 24 months in unopened original container under recommended storage conditions |
| Assaypurity | ≥98.0% (HPLC, on dried basis) as cefovecin sodium |
| Therapeuticcategory | Third-generation cephalosporin antibacterial for veterinary use |
| Mechanismofaction | Bactericidal; inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), causing cell lysis |
| Intendeddosageforms | Veterinary tablets, injections, capsules, powders, granules, premix, and solutions |
As an accredited Cefovecin 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 | Packaged in sealed double polyethylene bags inside aluminum foil pouches or fiber drums, net weight 25 kg per drum. |
| Container Loading (20′ FCL) | Container Loading (20′ FCL): Cefovecin Veterinary Grade API is packed in sealed drums/containers, loaded into a 20-foot full container for safe transport. |
| Shipping | Cefovecin Veterinary Grade API is shipped in sealed, inert containers to preserve purity and stability. Transport requires temperature-controlled conditions, protection from moisture and light, and full regulatory documentation for pharmaceutical handling. Shipments comply with international veterinary drug transport regulations, ensuring safe, traceable delivery worldwide. |
| Storage | Store Cefovecin Veterinary Grade API in a cool, dry place at controlled room temperature (20–25°C) or as specified, protected from light, moisture, and heat. Keep in tightly sealed, light-resistant containers. Avoid freezing. Ensure container remains closed when not in use to preserve potency and shelf life. |
| Shelf Life | Shelf life: 24 months when stored in a cool, dry place, protected from light and moisture, in original sealed packaging. |
For veterinary manufacturers sourcing cefovecin sodium as a sterile API, the only widely registered downstream presentation is a freeze-dried single-dose vial for reconstitution before subcutaneous administration in companion animals. The formulation addition ratio centres on 80 mg/mL cefovecin equivalent after reconstitution; a 10 mL diluent fill is combined with cefovecin sodium equivalent to 800 mg cefovecin. During bulk compounding, the API is dissolved in Water for Injection at a concentration equivalent to 80 mg/mL cefovecin, pH is adjusted with dilute sterile 0.1 N sodium hydroxide or hydrochloric acid, and the solution is passed through a 0.22 µm sterilising-grade polyethersulfone membrane. The filtered solution is aseptically filled into depyrogenated Type I glass vials, loaded onto freeze-dryer shelves, and lyophilised; primary drying is held below the cake collapse temperature, and secondary drying is terminated only when residual moisture by USP <921> Karl Fischer titration meets the product-specific acceptance criterion, typically ≤ 1.0% w/w. Production-scale freeze-dryers with shelf temperature control of ±1°C and condenser capacity above 20 kg ice per load require cycle separation by vial heat-transfer coefficient. Batch-to-batch variance in cake structure arises from fill depth, nucleation temperature, and residual oxygen in the headspace; collapsed or meltback cakes are rejected because reconstitution time and visible particulate counts shift relative to the registered product profile. Process compliance is demonstrated under 21 CFR Part 211, USP <71> sterility, USP <85> bacterial endotoxin, and USP <788> particulate matter requirements. Terminal product type is a lyophilized powder for solution for injection, supplied as a single-dose vial.
| Control point | Standard / method | Typical acceptance criterion | Production stage |
|---|---|---|---|
| Sterility | USP <71>, Ph. Eur. 2.6.1 | No microbial growth after incubation | Final product |
| Bacterial endotoxins | USP <85>, Ph. Eur. 2.6.14 | ≤ 50 EU/mL derived from 8 mg/kg dose and 0.1 mL/kg volume | Final product |
| Particulate matter ≥ 10 µm | USP <788> | ≤ 6000 particles/container | Final product |
| Particulate matter ≥ 25 µm | USP <788> | ≤ 600 particles/container | Final product |
| Residual moisture | USP <921> | Product-specific; typically ≤ 1.0% w/w for lyophilized cake | Primary drying |
| Elastomer closure integrity | USP <381>, Ph. Eur. 3.2.9 | No visible leakage; extractable profile within qualified limits | Sealing |
At the point of use, reconstitution of the lyophilized vial is carried out by adding 10 mL sterile water for injection to cefovecin sodium equivalent to 800 mg cefovecin to yield 80 mg/mL solution, and the terminal product type is a single-dose injectable solution administered only by the subcutaneous route in companion animals; use in food-producing animals or oral dosage forms is not an approved downstream application, and cephalosporin extra-label use in food-producing animals is prohibited under 21 CFR 530.41.
Bulk solution preparation for sterile filtration is performed by dissolving cefovecin sodium in Water for Injection at a target 80 mg/mL cefovecin equivalent. The solution pH is adjusted with dilute sodium hydroxide or hydrochloric acid to a registered band that minimises beta-lactam ring hydrolysis; excursions below 4.0 or above 7.0 accelerate pseudo-first-order degradation and generate particulate degradation products. Published data for cefovecin sodium under this exact aqueous matrix is limited; therefore, hold-time validation is conducted with stability-indicating high-performance liquid chromatography and not extrapolated from other cephalosporins.
Bioburden control is managed through a 0.45 µm prefilter followed by a 0.22 µm sterilising-grade polyethersulfone filter. The bulk hold between dissolution and completion of sterile filtration is typically limited to 4 h at 2–8°C in cephalosporin manufacturing, though the registered product-specific validated hold time may be shorter; dissolved-oxygen levels are monitored because oxygen uptake can accelerate free-radical side reactions in bicarbonate-buffered liquid systems and because microbial bioburden growth is aerobic. Terminal product type is sterile filtered bulk solution for lyophilization; compliance is demonstrated through 21 CFR Part 211 process validation and aseptic media fills under USP <71>.
The lyophilized cefovecin sodium cake is closed with halobutyl rubber stoppers selected for low moisture vapour transmission and low extractable burden. In this packaging scenario, the critical addition ratio is not API concentration but the stopper-to-vial compression set and headspace volume after sealing; the fill is targeted to a nominal 10 mL reconstituted volume, and the vial headspace is purged with nitrogen or sealed under partial vacuum before aluminium cap crimping. Residual moisture is measured by USP <921> Karl Fischer titration and is typically controlled to ≤ 1.0% w/w for the lyophilized cake; higher moisture levels reduce shelf life and may cause cake shrinkage, turbidity on reconstitution, or visible particulate counts exceeding USP <788> limits.
Closure qualification follows USP <381> and Ph. Eur. 3.2.9, including extractable and leachable profiling under stressed solvent conditions. Downstream sealing is performed on a high-speed stoppering station inside the freeze-dryer, followed by 100% visual inspection and leak testing; any vial with a defective crimp or stopper shift is rejected because moisture ingress after primary drying is a direct pathway for beta-lactam ring hydrolysis. Terminal product type is a sealed lyophilized powder for solution for injection.
Because cefovecin sodium in aqueous solution undergoes beta-lactam ring hydrolysis at elevated temperatures, terminal steam sterilisation of the filled solution is not the primary sterilisation route; the manufacturing train uses aseptic filtration and lyophilization. The formulation addition ratio for the filtered solution is 80 mg/mL cefovecin equivalent, with the filtered liquid filled at a volume equivalent to 800 mg cefovecin per vial. Terminal sterilisation would require thermal exposure that reduces potency, increases impurity profiles, and shifts reconstituted solution colour beyond product acceptance limits; therefore, sterility assurance is achieved through validated aseptic process simulation under USP <71> and environmental monitoring under 21 CFR Part 211.
The sterile API is received with a low bioburden specification and endotoxin control established under USP <85>. Downstream production includes depyrogenation of Type I glass vials at 250°C for not less than 30 min or an equivalent qualified cycle, aseptic filling with peristaltic or ceramic piston pumps, and stoppering under grade A air supply. Terminal product type is a single-dose injectable powder; any deviation in airflow, filter integrity, or glove dope transfer requires batch rejection because terminal sterilisation is not available to correct aseptic filling failures.
| Vial content | Diluent volume | Final concentration | Label dose | Volume per kg |
|---|---|---|---|---|
| 800 mg cefovecin equivalent | 10 mL water for injection | 80 mg/mL | 8 mg/kg | 0.1 mL/kg |
Subcutaneous dose calculation and endotoxin limit derivation for the 80 mg/mL reconstituted solution uses the labelled 8 mg/kg dog and cat dose. The maximum volume administered is 0.1 mL/kg, which under USP <85> and a 5 EU/kg endotoxin safety factor yields a final product endotoxin limit of 50 EU/mL; release testing therefore includes bacterial endotoxin analysis before distribution. Downstream production testing for the reconstituted solution includes visual inspection, particulate matter according to USP <788>, and sterility according to USP <71>. Terminal product type is the single-dose injectable solution prepared from reconstituted powder; redosing intervals beyond the registered label in off-label canine periodontal or feline lower urinary tract disease are not addressed here because published data for those specific configurations is limited.
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Cefovecin sodium is a third-generation cephalosporin antibiotic supplied as a veterinary-grade active pharmaceutical ingredient for further processing into sterile lyophilized injections, tablets, capsules, oral powders, granules, premixes, and aqueous solutions. The monosodium salt of cefovecin, identified by CAS registry number 234096-34-5, has a molecular mass of approximately 475 g/mol and a molecular formula of C17H18N5NaO6S2. Commercial supply is normally differentiated into sterile and non-sterile grades; the exact model designation is assigned by the API manufacturer. The API is a white to off-white hygroscopic powder, and its aqueous solubility is pH-dependent, with the sodium salt freely soluble in Water for Injections. The product is not intended for use in animals producing food for human consumption in most jurisdictions.
| Parameter | Test method | Control range |
|---|---|---|
| Appearance | Visual inspection | White to off-white powder |
| Identification | HPLC retention time, infrared absorption | Conforms to cefovecin sodium reference standard |
| Assay | HPLC per Ph. Eur. 2.2.29 | 95.0–102.0% on anhydrous basis |
| Water content | Karl Fischer titration, Ph. Eur. 2.5.12 | ≤2.0% |
| Related substances | HPLC per Ph. Eur. 2.2.29 | Total ≤2.0%; individual ≤0.5% |
| Residual solvents | VICH GL18(R2) | Conforms to Class 2 and Class 3 limits |
| Bacterial endotoxins, sterile grade | Ph. Eur. 2.6.14 | ≤0.05 EU/mg |
| Particulate matter, sterile grade | Ph. Eur. 2.9.19 | Meets test requirements |
Cefovecin is differentiated from ceftiofur and cefpodoxime primarily by its elimination kinetics in companion animals. The Summary of Product Characteristics for the injectable product reports a terminal elimination half-life in dogs of approximately 5.5 days and in cats of approximately 6.9 days. This extended persistence is associated with high reversible plasma protein binding, reported in the range of 96% to 98%, and slow renal clearance. Ceftiofur sodium and ceftiofur hydrochloride require once-daily administration in cattle and swine because the ceftiofur free acid metabolite is cleared more rapidly. Ceftiofur crystalline free acid suspension is formulated for extended release in livestock, but the dosing interval and species approvals differ from cefovecin. Cefpodoxime proxetil is an oral prodrug with lower systemic persistence and twice-daily or once-daily administration in dogs. Consequently, cefovecin is supplied predominantly as a sterile injection for single-dose administration at intervals of 7–14 days, whereas ceftiofur and cefpodoxime are compounded into injectable suspensions, intramammary preparations, or oral tablets. This pharmacokinetic difference imposes specific API handling requirements: high protein binding does not alter powder blending behaviour, but low dose strength and prolonged duration demand tight control of content uniformity and chemical purity.
The sterile grade is processed into a lyophilized cake for reconstitution. Aseptic filling uses depyrogenated Type I glass vials sealed with butyl rubber stoppers. The bulk solution is prepared in a stainless-steel jacketed vessel at 2–8°C to reduce hydrolysis. Sterilizing filtration is performed with a 0.22 µm polyethersulfone membrane, and the filtered solution is filled under Grade A laminar air flow. Lyophilization requires controlled ice nucleation and primary drying. Published cycle data for cefovecin sodium cake are limited, but the dried product is released only when cake moisture is ≤2.0% by Karl Fischer titration and the cake is intact. Bacterial endotoxin limits for the sterile API are typically ≤0.05 EU/mg. The finished vial is tested for sterility per Ph. Eur. 2.6.1, bacterial endotoxins per 2.6.14, particulate contamination per 2.9.19, and uniformity of content per 2.9.40 where applicable. Reconstitution with sterile water for injection to 80 mg/mL produces a solution that should be stored at 2–8°C and used within 28 days to avoid β-lactam degradation. Incompatibility with oxidizing agents and strong alkaline buffers is documented; these conditions accelerate hydrolysis of the β-lactam ring.
For tablets and capsules, the non-sterile crystalline powder is typically sieved through a 500 µm screen before blending. Published data for cefovecin tablet compression are limited; therefore, the process design space must be established for each formulation. Low-dose content uniformity requires that the API particle size distribution be controlled, with a d90 below 150 µm and a d50 in the range of 30–70 µm where direct compression is used. Blending is conducted in bin or V-blenders at 60–70% fill volume, and the starting moisture content is maintained below 2.0% to prevent agglomeration. Tablets are compressed on rotary tablet presses with target hardness 60–90 N. Friability is tested according to Ph. Eur. 2.9.7 and must be ≤1.0%. Capsule filling uses automatic capsule machines with tamping or dosator stations; the filled mass must remain within the limits of Ph. Eur. 2.9.5. Because cefovecin sodium is hygroscopic, direct contact with polyvinyl chloride packaging without desiccant is not recommended. Aluminum-aluminum blister or high-density polyethylene bottles with desiccant are preferred. In wet granulation, the β-lactam ring is susceptible to hydrolysis in aqueous binders; published data for this specific configuration are limited, and non-aqueous granulation or dry granulation is preferred.
Oral powders, granules, and premix intermediates are manufactured by geometric dilution of cefovecin sodium with lactose monohydrate or other carrier systems. The API is first blended with a portion of carrier, passed through a 250 µm screen, and then mixed in a ribbon blender at 20–30 rpm for 10–15 minutes. The mixture is filled into laminated aluminum bags to protect against light and moisture. Homogeneity is verified using Ph. Eur. 2.9.40 or an equivalent blending uniformity protocol; the relative standard deviation of content in 10 sampling locations is typically required to be ≤5.0%. For medicated feed premix, carryover limits are derived from the maximum residue limit or therapeutic dose. Cleaning validation must include swab and rinse sampling to prevent cross-contamination. The non-sterile API used in these forms has the same chemical purity requirements as the sterile grade but does not require bacterial endotoxin control.
Aqueous cefovecin sodium solutions degrade by β-lactam hydrolysis at a rate that is pH- and temperature-dependent. The reconstituted injection at 80 mg/mL is reasonably stable at 2–8°C for 28 days. Storage at room temperature reduces the acceptable use period and increases the appearance of degradation products. The lyophilized powder is stored in its original vial at controlled room temperature not exceeding 25°C. For oral solutions, pH adjustment must balance dissolution of the sodium salt against hydrolytic degradation; the target pH range is typically 5.0–7.0. Exposure to light accelerates discoloration, so amber glass or opaque packaging is specified. The degradation products are separated by liquid chromatography in accordance with Ph. Eur. 2.2.29; total related substances are controlled at ≤2.0% and any single unknown impurity at ≤0.5%. Published data for specific oral liquid cefovecin formulations are limited; stability-indicating methods must be validated under ICH Q1A(R2) and VICH GL3 conditions.
