| HS Code | 486616 |
| Chemical Name | Ethyl carbamate |
| Cas Number | 51-79-6 |
| Molecular Formula | C3H7NO2 |
| Molecular Weight | 89.09 g/mol |
| Appearance | White crystalline powder or colorless crystals |
| Solubility | Freely soluble in water, ethanol, ether, chloroform, and glycerol |
| Melting Point | 48-50°C |
| Boiling Point | 182-185°C at 760 mmHg |
| Log P Octanol Water | -0.15 |
| Stability | Stable under normal storage conditions; avoid exposure to strong oxidizers and strong bases |
| Storage Conditions | Store in a tightly closed container, protected from light and moisture, below 25°C |
| Compatible Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
As an accredited Ethyl Carbamate(Urethane) 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, light-resistant, tamper-evident containers suitable for pharmaceutical use. Supplied as veterinary-grade API in quantities of 1 kg, 5 kg, or 25 kg. |
| Container Loading (20′ FCL) | 20′ FCL: Drummed Ethyl Carbamate veterinary API loaded, secured, and ventilated for safe container transport. |
| Shipping | Ship as UN 2811, Toxic Solid, Organic, N.O.S. (Ethyl Carbamate/Urethane), Class 6.1, PG III. Pack in sealed, labeled drums or fiberboard containers, protected from moisture/light. Use dedicated hazmat transport, secure cargo, avoid foodstuffs, and follow MARPOL/IATA/IMDG/ADR depending on mode with proper documentation and placards. |
| Storage | Store Ethyl Carbamate (Urethane) Veterinary Grade API in tightly sealed, original containers in a cool, dry, well-ventilated area, protected from light and moisture. Keep away from heat, sparks, strong oxidizers, and acids. Maintain controlled room temperature, avoid contamination, and follow safety protocols for handling this potential carcinogen. Ensure proper labeling and segregation. |
| Shelf Life | Shelf life: 24 months in original tightly sealed container, stored below 25°C, protected from light and moisture. |
Preparation of injectable solutions for non-recovery surgical anesthesia in laboratory rodents and lagomorphs begins with dissolution of ethyl carbamate powder in sterile water for injection to a working concentration of 250 mg/mL to 400 mg/mL. In murine protocols, the intraperitoneal dose is commonly reported at 1.0 g/kg to 2.0 g/kg, while rabbit protocols in older literature report 0.8 g/kg to 1.2 g/kg depending on strain, age, and target anesthesia depth. Because IARC Monograph Volume 96 classifies ethyl carbamate as Group 2A — probably carcinogenic to humans — the material is restricted to terminal procedures in which animals are not permitted to recover. Institutional animal care and use committee records must identify the terminal endpoint, and where the procedure supports regulatory submissions, the study must conform to 21 CFR Part 58 Good Laboratory Practice and EU Directive 2010/63/EU with Annex IV documentation. Aseptic processing follows USP <797> low-risk compounded sterile preparation requirements and ISO 14644-1:2015 class 5 fill conditions. The solution is cold-sterilized through a 0.22 µm polyethersulfone membrane filter; terminal steam sterilization is not recommended unless product-specific thermal degradation data are generated, because published data on aqueous urethane stability above 100°C is limited. The final product is an injectable solution filled into amber Type I borosilicate vials of 20 mL or 50 mL nominal fill volume, closed with butyl rubber stoppers and sealed with aluminum flip-off caps. On filling lines, the main bottleneck is cold filtration throughput when the working concentration approaches 400 mg/mL; batch temperature is maintained at 20°C to 25°C because lower temperatures reduce solubility and may cause needle-line crystallization. Unused solution and rinse fluids must be collected and incinerated as hazardous waste.
In oral gavage and capsule compounding for non-clinical rodent protocols, the crystalline powder is processed through a stainless-steel cone mill fitted with a 0.5 mm screen to achieve a volume mean diameter (Dv50) between 45 µm and 180 µm. Dry blending with pregelatinized starch and microcrystalline cellulose is performed in a V-blender at 25 rpm for 15 minutes; total API loading ranges from 20% w/w to 80% w/w depending on target capsule fill weight and dose per kilogram. The compliance framework includes OECD GLP principles under OECD ENV/MC/CHEM(98)17, USP <905> uniformity of dosage units for capsules, and USP <701> disintegration testing. Disintegration is selected over dissolution because the API has high aqueous solubility and dissolution would not discriminate batch failures. For oral gavage, a 10% w/v solution in 0.9% saline is prepared within 2 hours of dosing and passed through a 70 µm nylon strainer to remove undissolved crystals. Encapsulation is performed on a dosator-type capsule filling machine, with hard gelatin capsule sizes 5 to 3 used for rodent oral administration. The terminal finished products are hard gelatin capsules and single-use amber oral dosing vials. Operational boundaries include humidity control; when ambient relative humidity exceeds 60%, the powder becomes cohesive and flow through the cone mill slows. Processing suites are held at 40% to 50% relative humidity and 18°C to 22°C to prevent sticking and agglomeration. Published data for this specific configuration is limited; institutional standard operating procedures rather than a harmonized veterinary monograph generally define the acceptance limits.
Immersion anesthesia of laboratory fish and aquatic amphibians uses ethyl carbamate as a prolonged-action bath agent when MS-222 is unsuitable due to species-specific pH sensitivity or local wastewater restrictions. A concentrated stock solution is prepared by dissolving 100 g of API in 1.0 L of deionized water, then diluted into tank water to a working concentration commonly cited in older literature at 1.0 g/L to 3.0 g/L for amphibian surgical anesthesia and 0.5 g/L to 1.5 g/L for teleost sedation. Water temperature is maintained at 18°C to 24°C, and dissolved oxygen is held above 6 mg/L during induction. Effluent containing the compound must be collected and incinerated through an approved hazardous waste stream; direct release into surface water is prohibited under the facility wastewater discharge permit. The terminal product type is an aqueous stock solution or a crystalline powder reconstitution kit marked for non-food aquatic species only. Because the compound is classified as Group 2A by IARC Monograph Volume 96, use is prohibited in aquatic species intended for human consumption. Compliance is driven by AAALAC International accreditation standards, EU Directive 2010/63/EU Article 33 provisions on animal welfare, and ISO 14001:2015 for effluent management. The main process conflict is induction depth control; at 3.0 g/L amphibians can reach surgical plane within 30 minutes, but recovery is not permitted due to carcinogenicity, so the bath is used only for terminal protocols or anesthesia followed by euthanasia.
Direct compression tablet and granule production for non-clinical oral sedation protocols requires powder flow control because ethyl carbamate has a low melting point near 49°C and can soften under compression heat. The tablet formulation uses 40% w/w to 80% w/w API with silicified microcrystalline cellulose, croscarmellose sodium, and 1% w/w magnesium stearate. Dry granulation by roller compaction at 4.0 MPa and 12 rpm is followed by oscillating granulator size reduction to a granule Dv50 of 250 µm; granules with USP <1174> compressibility index below 20% are fed to a rotary tablet press. Compression runs use 8 mm round biconvex tooling, turret speed below 30 rpm, and a cooled die table held at 15°C to 20°C to reduce die-wall sticking. Tablet hardness is controlled between 5 kp and 8 kp, and friability is tested according to USP <1216>. The terminal products are tablets intended for oral administration to non-food laboratory species in regulated experimental protocols. Analytical release testing follows ICH Q2(R1) for HPLC assay validation and USP <905> for uniformity of dosage units. Batch-to-batch variance in powder flow increases above 70% w/w API; the addition of 1% w/w fumed silica restores flow function coefficient but may reduce compactibility, so the formulation is optimized by pilot blend studies. Published data for clinical veterinary sedation with this compound is limited; current use is restricted to protocol-defined non-clinical studies and historical veterinary literature references.
Dry granulation of ethyl carbamate for research animal dietary premix is performed only for non-food species, because carryover into food-producing animals would generate residues with unacceptable genotoxic risk under food safety frameworks. The formulation combines 10% w/w API with 89% w/w micronized brewer’s yeast or dextrose carrier and 1% w/w fumed silica as a flow conditioner. Mixing is performed in a pharmaceutical V-blender at 25 rpm for 20 minutes; homogeneity is verified by taking ten stratified samples per lot and analyzing via fit-for-purpose HPLC validated under ICH Q2(R1), with acceptance limits of 5% RSD. The granules are packaged in 1 kg to 5 kg HDPE containers with integrated desiccant. The terminal product is a powder premix intended solely for incorporation into non-food laboratory rodent diets at no more than 0.5% w/w of final feed; published data for this specific configuration is limited. Manufacturing compliance references 21 CFR 211.84 for component testing and OECD GLP for non-clinical laboratory studies. Dedicated equipment is required because the material is classified as a probable human carcinogen by IARC Monograph Volume 96; cleaning validation uses health-based exposure limits derived from site-specific toxicological assessment, and wash water is collected for hazardous waste incineration. Cross-contamination control is the critical process bottleneck: the low melting point of the API makes dry-cleaning preferable to hot-water washing, and residue removal is verified by swab sampling of mixer baffles, discharge gates, and container contact surfaces.
| Dosage form | Typical API loading or working concentration | Process control | Test or compliance standard | Finished product type |
|---|---|---|---|---|
| Injectable solution | 250 mg/mL – 400 mg/mL | Cold filtration, 0.22 µm PES, class 5 fill | USP <797>, ISO 14644-1:2015, 21 CFR Part 58 | Amber Type I borosilicate vial, 20 mL – 50 mL |
| Oral gavage solution | 10% w/v in 0.9% saline | 70 µm strainer, prepare within 2 h | OECD GLP, USP <701> | Single-use amber oral dosing vial |
| Capsule | 20% w/w – 80% w/w | Cone mill Dv50 45 µm – 180 µm, dosator fill | USP <905>, USP <701> | Hard gelatin capsule, sizes 5 – 3 |
| Tablet | 40% w/w – 80% w/w | Roller compaction 4.0 MPa, cooled die table | USP <1174>, USP <1216>, USP <905> | Biconvex tablet, 8 mm round tooling |
| Powder/granule | 10% w/w – 80% w/w depending route | V-blender 25 rpm, 15 min – 20 min | ICH Q2(R1), USP <1174> | HDPE container with desiccant, 1 kg – 5 kg |
| Premix | 10% w/w API in premix; final feed max 0.5% w/w | Stratified sampling, 5% RSD acceptance | 21 CFR 211.84, OECD GLP | Non-food rodent dietary premix |
| Immersion solution | Stock 100 g/L; working 0.5 g/L – 3.0 g/L | Temperature 18°C – 24°C, DO > 6 mg/L | EU Directive 2010/63/EU, ISO 14001:2015 | Non-food aquatic stock solution or reconstitution kit |
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Ethyl carbamate (urethane, CAS 51-79-6; molecular formula C₃H₇NO₂; molecular mass 89.09 g/mol) is supplied as a white crystalline solid with a melting range of 48–50°C and a boiling range of 182–184°C. The veterinary-grade API presentation is intended for formulation into tablets, injections, capsules, powders, granules, premix, and solutions. The supplier’s model designation typically associates an internal code with route-specific physical form: a low-endotoxin code for injectable use, a controlled-particle-size code for direct-compression tablets or capsule filling, and a coarse code for feed premix blending. No harmonized naming convention exists across manufacturers. Because no pharmacopoeial monograph for veterinary urethane is established in USP–NF, Ph. Eur., or VICH, the term “veterinary grade” is a manufacturer-defined specification set rather than a compendial identity. The certificate of analysis, the validated analytical methods, and the stability file therefore function as the controlling release documents.
The simple carbamate ester structure hydrolyzes under acidic or alkaline conditions, releasing ethanol and ammonia. This hydrolysis sensitivity directly influences sterilization, granulation, container–closure selection, and shelf-life strategy. The material is freely soluble in water and ethanol, which supports aqueous injection and oral solution matrices, but the low melting range creates specific constraints during tablet compression, capsule filling, and feed pelleting. The following sections identify the parameters that separate veterinary-grade material from technical-grade urethane and from analytical reference standards.
Technical-grade urethane typically serves as a chemical intermediate or laboratory reagent and may contain urea, ethanol, or metal residues from synthesis. Veterinary API material must meet more stringent residual solvent, elemental impurity, and particulate controls. The values in Table 1 represent a manufacturer-specific release profile for a veterinary-grade material; the absence of a harmonized monograph means limits may differ among suppliers and must be qualified case-by-case.
| Parameter | Veterinary-grade release limit | Technical-grade typical | Method |
|---|---|---|---|
| Assay, anhydrous C₃H₇NO₂ | 99.0–101.0% | ≥98.0% | GC-FID with internal standard |
| Melting range | 48–50°C | 47–50°C | USP <741> / Ph. Eur. 2.2.15 |
| Water content | ≤0.5% w/w | ≤1.0% w/w | Karl Fischer titration, USP <921> Method Ia |
| Residue on ignition | ≤0.10% w/w | ≤0.30% w/w | USP <281> |
| Heavy metals, as lead | ≤10 ppm | ≤20 ppm | USP <231> or ICP-MS |
| Residual ethanol | ≤5000 ppm | ≤10,000 ppm | GC-HS; ICH Q3C Class 3 |
| Particle-size D90, solid grades | ≤150 μm or CoA-controlled | Not routinely controlled | Laser diffraction, ISO 13320 |
| Bacterial endotoxins, parenteral use | <2.5 EU/mg | Not specified | USP <85> / Ph. Eur. 2.6.14 |
Compared with an analytical reference standard, veterinary-grade urethane may carry a slightly wider assay interval but adds controlled particle-size distribution and, for injectable use, endotoxin release testing. Compared with technical-grade material, the veterinary product differs primarily in lower residue on ignition, lower residual ethanol, and the addition of particle-size and endotoxin controls. Those differences are not cosmetic: high ash content accelerates punch wear in tablet compression, and a broad or coarse particle-size distribution promotes content uniformity failure in low-dose tablet and capsule products. Assay detection is preferably performed by GC-FID because the molecule lacks a strong chromophore for ultraviolet detection. Elemental impurities require an ICH Q3D risk assessment; cadmium, lead, arsenic, and mercury should be verified by ICP-MS when catalyst residues are a plausible route-dependent risk.
Ethyl carbamate is freely soluble in water; aqueous stock solutions can be prepared at the intended final concentration for parenteral administration. The ester linkage is susceptible to hydrolysis, and published kinetic data specific to veterinary urethane injection formulations are limited. Terminal steam sterilization at 121°C for 15 min should therefore be avoided unless forced degradation studies demonstrate adequate stability of the active and all degradants. Aseptic processing through a 0.22 μm membrane filter under ISO 14644-1 Class 5 conditions is the lower-risk route for injectable presentations. Solutions should be filled into Type I borosilicate glass vials or non-reactive copolymer containers. Absence of photostability data under ICH Q1B requires storage in light-protective packaging. The pH should be maintained between 6.0 and 7.0 to reduce hydrolysis rate while remaining compatible with physiological administration. Endotoxin testing per USP <85> and sterility testing per USP <71> are expected for injectable batches.
For oral solutions and liquid concentrates, the low melting point of the dry API is less critical than hydrolytic stability. A stability-indicating method should be validated under ICH Q2(R1) before using the solution in long-term laboratory animal studies. The method should detect ethanol and ammonia or ammonium ion as degradation markers. For tablets and capsules, dry processing is preferred. Direct compression is feasible when the D90 is ≤150 μm and the drug load is low; microcrystalline cellulose, lactose monohydrate, and sodium starch glycolate are common carriers. Wet granulation with an aqueous binder requires the bed temperature to remain below 35°C to avoid surface melting and agglomeration on the granulator bowl. Roller compaction with cooled rolls is preferred over slugging because repeated compaction generates frictional heat. Capsule filling equipment with dosator or tamping mechanisms should be set to minimize compression work; otherwise the fill plug can soften and cause weight variation. Rotary tablet presses with chilled punch tips should be used, and ejection force should be monitored because low-melting-point APIs can film on punch faces.
Medicated premix and powder formulations demand homogeneous distribution through mash or pelleted feed. Pellet conditioning above 48°C can cause partial melting and die-face buildup, so cold pelleting or post-pellet spraying is specified. If post-pellet spraying is selected, the liquid carrier must dissolve urethane completely; ethanol or water may be used, but ethanol evaporation from the finished feed must be verified against the ICH Q3C limit for residual solvent. Dry premix blending should use a ribbon blender filled to 60–70% of working capacity, with a carrier particle size matched to the API.
Stratified sampling at 10 points and assay by a validated method should show relative standard deviation ≤5.0% before discharge. Powders and granules intended for oral syringe administration should be sieved through a 180 μm screen to prevent clogging of oral dosing tips. For low-dose products, geometric dilution is used to avoid segregation; a coarse D90 above 150 μm may separate from finer excipients during bin transfer and should be milled through a cone mill equipped with a 0.5 mm screen. Mix uniformity testing should follow USP <905> for finished units or a stratified powder blend protocol. No maximum residue limit has been established for ethyl carbamate in edible tissues, so use in food-producing animals is not acceptable under residue-control programs.
Because ethyl carbamate is not currently approved by the FDA Center for Veterinary Medicine or the European Medicines Agency for therapeutic use in food-producing animals, any regulatory submission must be built on a manufacturer-specific technical file. Release testing should include identity, assay, water, residue on ignition, residual solvents per USP <467> or ICH Q3C, elemental impurities per ICH Q3D, and, for injectable presentations, sterility per USP <71> and endotoxin per USP <85>. Tablets and capsules should demonstrate uniformity of dosage units per USP <905>. Stability protocols should follow VICH GL3 and VICH GL5 with bracketing or matrixing only where justified by development data.
| Regulation / Standard | Scope | Application to urethane veterinary-grade release |
|---|---|---|
| ICH Q3C | Residual solvents | Ethanol Class 3; limit ≤5000 ppm; no Class 1 solvents permitted |
| ICH Q3D | Elemental impurities | Risk assessment; Class 1 and 2A elements by ICP-MS |
| USP <467> | Residual solvents | Alternative method to verify ethanol and any synthesis-derived solvents |
| USP <905> | Uniformity of dosage units | Tablets and capsules intended for dose-controlled administration |
| USP <71> | Sterility | Injectable presentations |
| USP <85> | Bacterial endotoxins | Parenteral presentations; limit <2.5 EU/mg |
| VICH GL3 | Stability testing | Storage conditions, intervals, and forced degradation |
| FDA 21 CFR 211 | cGMP | Finished dosage manufacturing and packaging controls |
| REACH (EC) 1907/2006 | Substance supply | Registration, safety data sheet, and exposure scenario |
Dispensing, milling, and blending of urethane veterinary-grade API require containment consistent with an occupational exposure limit derived from its carcinogenicity classification; IARC classifies urethane in Group 2A. Closed material transfer, dedicated weigh-room balance with HEPA-filtered exhaust, and local exhaust ventilation should be specified. Cleaning validation for shared equipment should use a validated analytical method with a limit of detection below the toxicological threshold; no published acceptance limit exists, so the limit must be calculated from the permitted daily exposure for the target species and route. The material should be stored in tightly closed containers at controlled room temperature, protected from light and moisture. Industrial-grade urethane must not be substituted for veterinary-grade material without full impurity and particle-size qualification because the technical product may introduce metal residues, excess ethanol, or uncontrolled particle size into the finished dosage form.
