| HS Code | 158586 |
| Product Name | Adrenosem Veterinary Grade API |
| Active Ingredient | Carbazochrome Salicylate |
| Synonyms | Adrenochrome monosemicarbazone salicylate |
| Cas Number | 13051-02-0 |
| Molecular Formula | C10H12N4O3 · C7H6O3 (C17H18N4O6) |
| Molecular Weight | 374.35 g/mol |
| Appearance | Red to orange-red crystalline powder |
| Solubility | Soluble in water; slightly soluble in ethanol |
| Grade | Veterinary grade |
| Intended Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Purity | 98.0% - 101.0% on dried basis by HPLC |
| Storage | Store in a cool, dry, well-ventilated place, protected from light and moisture |
| Shelf Life | 24 months |
| Pharmacological Action | Capillary hemostatic; reduces capillary bleeding and capillary permeability |
As an accredited Adrenosem 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 | Adrenosem Veterinary Grade API is packaged in sealed, light-protected drums and bags, with various quantities, for tablet, injection, capsule, powder, and premix manufacturing. |
| Container Loading (20′ FCL) | One 20' FCL container holds Adrenosem veterinary-grade API, securely packed in sealed drums for tablets, injections, capsules, powders, and more. |
| Shipping | Our veterinary-grade Adrenosem API is shipped in sealed, tamper-evident containers with proper hazardous material labeling. We follow global transport regulations, providing COA, MSDS, and handling documentation. Temperature-controlled and moisture-protected packaging ensures stability. International shipping via air, sea, or courier is arranged with chain-of-custody tracking for safety and compliance. |
| Storage | Store Adrenosem Veterinary Grade API in tightly sealed, light-resistant containers in a cool, dry, well-ventilated area, ideally between 15–30°C. Protect from moisture, humidity, and direct sunlight. Keep away from incompatible substances. Ensure container remains closed when not in use. Under these conditions, the material maintains stability for use in tablets, injections, capsules, powders, granules, premixes, and solutions. |
| Shelf Life | Shelf life: 24 months from manufacture date when stored in original, tightly closed containers under controlled conditions. |
Adrenosem Veterinary Grade API, supplied as the salicylate salt of carbazochrome for oral solid, powder, granule, and premix applications and as the sodium sulfonate salt for aqueous injectable and solution applications, is directed into six downstream production routes. The active is not a coagulation factor replacement; it is formulated only for clinical presentations where capillary stabilization is the intended mechanism and where local regulatory approval exists. The following application scenarios cover companion-animal tablets, perioperative injections, compounded hard gelatin capsules, drinking-water powders, medicated feed premixes, and neonatal oral solutions. Each route specifies the applicable compliance framework, formulation addition ratio, production process parameters, and terminal product types without cross-transfer of generic formulation language across routes.
In the manufacture of companion-animal hemostatic tablets, the salicylate salt is incorporated at a formulation addition ratio of 0.75–2.0% w/w of the core tablet mass. At a total tablet mass of 80 mg, this range corresponds to a unit dose of 0.6–1.6 mg, with 1.0 mg as the reference strength. Content uniformity is controlled under USP <905>, and disintegration is verified under USP <701> with a 30-minute limit in 0.1 N hydrochloric acid at 37±2°C. The compliance framework further requires residual solvent assessment under VICH GL18, elemental impurity risk evaluation under ICH Q3D, and batch release under 21 CFR 211. The downstream production process begins with a 1:10 geometric pre-blend of the API and microcrystalline cellulose PH-102, followed by a main tumble blend with lactose monohydrate, croscarmellose sodium, and magnesium stearate at 15 rpm for 20 minutes. Production-scale failures during direct compression have been traced to hopper discharge segregation when the pre-blend is held beyond 30 minutes or when the blend Carr index exceeds 25; baffled hoppers and a maximum hold time of 20 minutes are therefore specified. Compression is performed on a rotary tablet press equipped with 8 mm round flat-faced punches and a pre-compression stage at 1.5–3.0 kN, followed by main compression at 5–12 kN depending on blend lubrication. In-process tests include tablet hardness 4–8 kp, friability ≤1.0%, and disintegration ≤30 minutes. If the incoming API lot has a loss on drying greater than 0.5%, tray drying at 40°C for 4 hours is required before weighing. Amine-containing lubricants or coating additives are avoided because primary amine groups react with the semicarbazone carbonyl and reduce assay under accelerated stability. Terminal product types are 0.5 mg, 1.0 mg, and 2.0 mg round scored tablets packed in amber HDPE bottles with desiccant, with stability zones assigned according to ICH climatic zone IVb where tropical veterinary distribution is anticipated.
In perioperative bleeding management for cattle and swine, the sodium sulfonate salt is converted into a sterile aqueous injection at a formulation addition ratio of 0.5% w/v in 10 mL vials and 1.0% w/v in 50 mL vials. The finished product must satisfy USP <1> Injections, USP <71> Sterility Tests, and USP <85> Bacterial Endotoxins with a limit of ≤0.5 EU/mg of API, while aseptic processing conforms to EU GMP Annex 1 (2022) and batch release follows 21 CFR 211. The production process begins with dissolution of the sodium sulfonate salt in Water for Injection at 25±2°C under low-speed agitation. Tonicity is adjusted with sodium chloride to 280–320 mOsm/kg, and the solution is buffered with citric acid/sodium citrate to pH 5.5–6.5. The solution is sparged with nitrogen, passed through a 0.22 µm PVDF membrane filter, and filled into amber Type I glass vials under Grade A laminar airflow. Steam-in-place cycles on transfer lines and filter integrity testing by bubble point are executed per batch. The critical production window is tight: solution temperature above 30°C accelerates chromophore degradation, while pH below 4.0 may precipitate the active and pH above 7.0 promotes oxidative discoloration. Manufacturing bays therefore use sodium-vapor lighting, nitrogen overlay, and an oxygen headspace limit of ≤2.0% v/v. Filling line hold time is limited to 2 hours at 20–25°C. The terminal product types are 10 mL and 50 mL amber glass vials for intravenous, intramuscular, or subcutaneous administration, with a limitation that the sterile injectable is not indicated as a substitute for coagulation factor replacement and is not used in confirmed thrombocytopenia or hereditary coagulopathy.
The production of patient-specific hard gelatin capsules from the salicylate salt in veterinary compounding pharmacies and 503B outsourcing facilities requires a formulation addition ratio of 0.25–1.5 mg per capsule, with a 1:10 and 1:100 geometric dilution sequence in pregelatinized starch and lactose monohydrate to achieve content uniformity. This process is performed under USP <795> for nonsterile preparations, with potency verification by HPLC against a certified reference standard and a water activity limit of ≤0.60 to support beyond-use dating. Outsourcing facilities that batch-compound must also operate under 21 CFR 210 and 21 CFR 211, while residual solvent and elemental impurity data transfer is guided by VICH GL18 and ICH Q3D. The downstream production process uses low-shear tumble blending in a V-blender at 15 rpm for 15 minutes after geometric dilution; capsules are filled on a semi-automatic dosator machine or an intermittent capsule filler, with weight checks every 5 minutes and metal detection before release. The principal failure mode is adhesive loss of the low-density API to unlined stainless steel surfaces; bowl and paddle liners of polytetrafluoroethylene are specified, and the fill powder is pre-conditioned at ≤40% relative humidity. Terminal product types include size 3 and size 4 hard gelatin capsules in strengths of 0.5 mg, 1 mg, 2 mg, and 5 mg, dispensed in amber vials with desiccant and labeled with a beyond-use date assigned according to water activity and packaging integrity.
A water-soluble powder for mass medication in broiler and swine drinking-water systems incorporates the salicylate salt at a formulation addition ratio of 0.05–0.15% w/w of the finished powder, with final concentration adjusted to deliver the approved species dose through a 1:1000 dilution in drinking water. The powder system is dry-blended with anhydrous dextrose, sodium citrate, and amorphous silica in a ribbon mixer; the API is first micro-milled to a particle size D90 ≤75 µm to ensure rapid dispersion and prevent nozzle blockage in proportioner medicators. Blend uniformity is checked by sampling 10 points across the mixer at 10, 15, and 20 minutes, with an acceptance criterion of RSD ≤5.0% and assay 90–110% of label. The compliance package for this route includes Regulation (EU) 2019/6 for veterinary medicinal product registration, VICH GL18 residual solvents, ICH Q3D elemental impurities, and current good manufacturing practice under 21 CFR 211; if marketed as a medicated drinking-water product, local residue withdrawal and feed safety conditions also apply. Production-scale batch records from tropical humid sites identify caking and discoloration as the primary defects when relative humidity exceeds 60% during sifting and packing; packaging lines therefore operate at ≤40% RH and the finished powder is heat-sealed in foil-lined sachets. Water line pressure for proportioner pumps should be regulated at 2–4 bar to reduce dose fluctuation. Terminal product types include 100 g, 500 g, and 1 kg foil sachets for drinking-water application, with dosing pumps calibrated at 1–5 L/min and a 24-hour stock solution stability window where water quality permits.
The production of a feed premix from the salicylate salt for swine grower-finisher rations uses a formulation addition ratio of 2–10 g of API per kg of premix carrier, with a further 1:100 dilution into complete feed to yield a final dietary concentration in the milligram-per-tonne range as authorized. Premix manufacture falls under Regulation (EU) 2019/4 on medicated feed and Regulation (EC) No 183/2005 on feed hygiene; in the United States, feed-use approval requires alignment with 21 CFR Part 558 only where an approved new animal drug label exists. The production process employs a horizontal double-shaft paddle mixer with a working capacity of 500 kg; the API is first adsorbed onto finely divided calcium carbonate or wheat middlings in a 1:10 pre-mix, then discharged into the main mixer for 20 minutes. Homogeneity acceptance is based on 12 sample points with a coefficient of variation ≤5.0% for active assay, and cross-contamination carryover is limited to ≤1.0% of the previous batch. The main processing conflict is redox instability when the API contacts ferrous sulfate or copper sulfate in trace mineral premixes; batch logs show accelerated chromophore degradation and loss of assay when the API is co-mixed with ferrous sulfate at moisture levels above 12%. Mineral packages are therefore added as a separate micro-ingredient stream, or the active premix is protected with a moisture-barrier bag. Terminal product types include 5 kg, 10 kg, and 25 kg multi-wall paper bags with polyethylene liners, labeled for use in swine grower-finisher rations under veterinary supervision.
| Production route | Product quality standards | Process control thresholds | Terminal presentations |
|---|---|---|---|
| Oral tablet | USP <905>, USP <701>, ICH Q3D, VICH GL18 | Blend RSD ≤5.0%; compression force 5–12 kN; friability ≤1.0% | 0.5 mg, 1 mg, 2 mg HDPE bottles |
| Sterile injection | USP <1>, USP <71>, USP <85>, EU GMP Annex 1 | pH 5.5–6.5; osmolality 280–320 mOsm/kg; headspace oxygen ≤2.0% v/v | 10 mL, 50 mL amber Type I glass vials |
| Compounded capsule | USP <795>, 21 CFR 210, 21 CFR 211 | Geometric dilution 1:10, 1:100; water activity ≤0.60; RH ≤40% | Size 3 and size 4 hard gelatin capsules, 0.5–5 mg |
| Water-soluble powder | Regulation (EU) 2019/6, VICH GL18, ICH Q3D | Particle size D90 ≤75 µm; blend RSD ≤5.0%; packaging RH ≤40% | 100 g, 500 g, 1 kg foil sachets |
| Medicated feed premix | Regulation (EU) 2019/4, Regulation (EC) No 183/2005, 21 CFR Part 558 where approved | Mixer coefficient of variation ≤5.0%; carryover ≤1.0%; moisture ≤12% | 5 kg, 10 kg, 25 kg polyethylene-lined bags |
| Oral solution | USP <51>, USP <61>, USP <62>, 21 CFR 211 | pH 5.0–6.0; viscosity 3–8 mPa·s; water hardness ≤200 ppm calcium carbonate equivalent | 100 mL, 250 mL, 500 mL amber bottles |
Neonatal calf and piglet oral solutions containing the sodium sulfonate salt are compounded at a formulation addition ratio of 0.1–0.3% w/v in an aqueous vehicle composed of sorbitol solution, sodium citrate buffer, and a preservative blend of methylparaben or potassium sorbate, depending on regional preservative allowances. The product is designed for oral drench or nipple administration and is manufactured under 21 CFR 211, with preservative effectiveness testing per USP <51> and microbial limits per USP <61> and USP <62>; residual solvents are assessed under VICH GL18 and elemental impurities under ICH Q3D. The production process dissolves the API in purified water at 20–25°C, then adds sorbitol solution to adjust vehicle viscosity to 3–8 mPa·s; pH is controlled to 5.0–6.0 with citrate buffer, and sodium metabisulfite is added at ≤0.1% w/v as an oxygen scavenger. The solution is sparged with nitrogen, filtered through a 5 µm clarifying filter, and filled into amber multi-dose bottles with child-resistant closures. Production-scale issues include microbial proliferation in the dosing pump and precipitation of the API when local water hardness exceeds 200 ppm calcium carbonate equivalent; therefore, purified water rather than potable water is used, and all transfer lines are cleaned with hot 0.1 N sodium hydroxide before each batch. Terminal product types include 100 mL, 250 mL, and 500 mL amber oral solution bottles with graduated dosing cups, supplied with a 5 mL oral drench syringe for calves or piglets.
Competitive Adrenosem Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions prices that fit your budget—flexible terms and customized quotes for every order.
For samples, pricing, or more information, please contact us at +8615365186327 or mail to admin@ascent-chem.com.
We will respond to you as soon as possible.
Tel: +8615365186327
Email: admin@ascent-chem.com
Flexible payment, competitive price, premium service - Inquire now!
Adrenosem Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a single-molecule active pharmaceutical ingredient identified as carbazochrome salicylate, CAS 13051-01-9. The listing denotes seven compatible finished-dosage presentations, not seven separate chemical entities or potencies. The product model is the veterinary-grade API lot supplied as a non-sterile crystalline powder for further pharmaceutical manipulation; no separate finished-pack model number applies. Compendial control for carbazochrome salicylate is most commonly anchored to the Japanese Pharmacopoeia monograph, which sets assay on the dried basis at not less than 98.0%, loss on drying not more than 0.5%, and residue on ignition not more than 0.10%. Because the material is intended for use in multiple route-specific veterinary formulations, vendor certificates of analysis routinely include residual solvents under ICH Q3C, microbial enumeration under harmonized Ph. Eur. 5.1.4, and related substances by liquid chromatography. The API is used in veterinary hemostasis protocols that target capillary oozing and microvascular bleeding after surgical procedures, dental extraction, or localized fragility of the capillary bed. It is not indicated for arterial hemorrhage, fibrin clot deficiency, thrombocytopenia, or vitamin K-responsive coagulopathy. Mechanistically, the molecule acts by increasing capillary resistance and reducing capillary permeability; it does not constrict blood vessels and it does not directly activate coagulation factors or platelets. The salicylate counterion modifies aqueous solubility and dissolution behavior and distinguishes this material from plain adrenochrome semicarbazone or adrenochrome monosemicarbazone sodium sulfonate. This distinction is relevant in method transfer and in formulation because hydrolytic degradation can release free salicylic acid, and the resulting pH shift can alter dissolution, injection-site tolerance, and related-substances profiles.
Direct compression of carbazochrome salicylate is constrained by powder flow and compactability rather than chemical assay. The material may fall into the pharmacopoeial “poor flow” classification, and the angle of repose should be measured according to USP <1174>; values above 40° indicate that glidant addition is required before tablet compression. Bulk density and tapped density are measured according to USP <616> because a low bulk density can widen die-fill variation on rotary presses. If the API is compressed as a direct-compression blend containing 10.0% carbazochrome salicylate, the powder feed system may require a paddle feeder speed below 20 rpm and a press speed below 60 rpm, depending on tooling configuration. These are operational limits rather than fixed values because published data for this specific API at production scale is limited. A final blend with microcrystalline cellulose of nominal mean particle size 100 µm and colloidal silicon dioxide at 0.5–1.0% w/w is commonly prepared, followed by magnesium stearate at 0.25–0.75% w/w. Compression force below 8 kN and tablet hardness below 40 N may be insufficient to survive film coating, and friability testing should confirm a loss of not more than 1.0% according to USP <1216>. Tooling sticking is managed by controlling relative humidity below 60% and by adding the lubricant in the final blending step. Direct compression is used when dose uniformity can be achieved without exposing the heat-sensitive API to wet granulation.
Injectable solutions of carbazochrome salicylate require a different control strategy because the salicylate complex undergoes pH-dependent hydrolysis and oxidative discoloration. In aqueous media above pH 6.5, the solution can darken and release salicylic acid; below pH 4.0, precipitation may occur during chilled storage. The finished solution is therefore targeted at pH 4.5–6.0, with osmolality adjusted to 280–300 mOsm/kg using sodium chloride or dextrose. Dissolved oxygen should be reduced by nitrogen sparging before filling, and the filled ampoules or vials are protected from visible light with amber glass or a light-blocking secondary package. Terminal sterilization at 121 °C for 15 min is common for parenteral products, but the heat input must be validated for carbazochrome salicylate because hydrolysis can increase sub-peaks in the related-substances chromatogram by the end of the cycle. Published data for this specific configuration is limited; manufacturers therefore monitor assay, pH, absorbance at 480 nm, and particulate matter after thermal stress. Filtration with a 0.22 µm membrane filter is positioned before sterile filling, and the final product must meet USP <85> bacterial endotoxin criteria for injectables. The API lot used for parenteral manufacture should have an endotoxin acceptance limit of <0.20 EU/mg and a microbial enumeration limit consistent with Ph. Eur. 5.1.4. Phosphate-based buffering is not recommended because the salicylate concentration may exceed the solubility product of sparingly soluble phosphate salts at low storage temperatures. The use of antioxidants such as sodium metabisulfite can be evaluated, but compatibility with the semicarbazone chromophore must be confirmed by forced-degradation studies under ICH Q1B light exposure. For intramuscular administration, injection-site irritation is managed by pH control and by limiting the dose volume per site; however, published species-specific pharmacokinetic data for carbazochrome salicylate in veterinary target animals is limited.
The release specification for Adrenosem Veterinary Grade API is compound-specific but presentation-sensitive. A standard non-sterile API certificate includes the monograph tests for appearance, identification, assay, related substances, loss on drying, residue on ignition, and residual solvents. For injection-grade lots, endotoxin and microbial enumeration limits are added. The table below summarizes the core specification indicators. Vendor results should be numerical and should reference the method designation, not only a pass/fail statement, because downstream formulation decisions depend on quantitative trends, particularly in related substances and particle-size distribution.
| Test parameter | Acceptance criterion | Reference method / standard |
|---|---|---|
| Appearance | Light orange to orange-red crystalline powder; no visible foreign matter | Visual; JP monograph |
| Identification | IR spectrum concordant with reference standard; retention time concordant with reference standard | JP infrared absorption spectrophotometry; HPLC |
| Assay (dried basis) | Not less than 98.0% | JP monograph liquid chromatography |
| Loss on drying | Not more than 0.5% | JP drying method |
| Residue on ignition | Not more than 0.10% | JP ignition method |
| Heavy metals | Not more than 20 ppm | JP heavy metals limit test |
| Residual solvents | Ethanol ≤5000 ppm; methanol ≤3000 ppm unless otherwise justified | ICH Q3C Class 3 |
| Microbial enumeration | TAMC ≤10² CFU/g; TYMC ≤10² CFU/g; absence of Staphylococcus aureus and Pseudomonas aeruginosa | Ph. Eur. 5.1.4 |
| Bacterial endotoxin | <0.20 EU/mg for parenteral-grade lots | USP <85> |
Additional tests for particle-size distribution and bulk density are not compendial release criteria but are routinely included in vendor technical data sheets because they control downstream blend uniformity and tablet weight variation. Raw-material storage is defined by the manufacturer’s stability data, but the API should be kept in a tightly closed, light-resistant container at controlled room temperature. Because the salicylate complex is hygroscopic above 60% relative humidity, containers should not be opened for prolonged periods in humid production suites. Retest periods of 12, 24, or 36 months can be assigned only after long-term stability studies according to ICH Q1A or a justified reduced protocol. Bulk powder sampled from partially used containers should be tested for moisture content before direct compression because surface moisture can alter flow and compactability. A low-humidity pass-box is recommended for transfer into dry-processing areas.
Wet granulation may be selected when the API concentration is below 5.0% w/w or when a feed premix must survive distribution without segregation. The process introduces moisture and heat; therefore, the hydrolytic stability of the salicylate complex should be confirmed by a forced-degradation study before committing to aqueous granulation. A commonly evaluated granulation formulation uses povidone solution at 2.5% w/w and drying at 65 °C to a final loss on drying of 1.5–2.0%; the resulting particle-size and density values depend on mixer type, binder viscosity, and spray rate, and published data for this specific API is limited. In low-shear mixer granulators, typical target ranges are a median particle size of 180–250 µm and a bulk density of 0.52–0.58 g/cm³ for similar low-dose, poorly water-soluble actives. The final granules are screened through a 1.0 mm screen, and fines below 75 µm are limited to <20% by mass to reduce segregation. For powders and premixes, geometric dilution in a V-blender or bin blender is performed at 60–70% of nominal container volume; blend uniformity sampling at 3 positions per batch should meet 95–105% of label claim. Moisture uptake above 60% relative humidity can form hard agglomerates, so packaging in heat-sealed foil laminate with desiccant is used. If long-term storage in tropical veterinary distribution chains is anticipated, the moisture vapor transmission rate of the packaging should be below 0.1 g/m²/day at 25 °C/75% RH.
For capsule and powder presentations, the API is dry-mixed rather than wet-granulated when the dose is low and the formulation is moisture-sensitive. A hydrophobic carrier such as microcrystalline cellulose or pregelatinized starch is used to reduce agglomerate formation, and the blend is passed through a 1.0 mm sieve before capsule filling. Capsule fill weight and dissolution consistency depend on the uniformity of API distribution across the carrier surface; therefore, the blend should be sampled at the beginning, middle, and end of the filling campaign and assayed against the 95–105% label-claim interval. Powder blends intended for reconstitution into oral solutions should be assessed for reconstitution time, pH, and related substances after standing at controlled room temperature for the in-use period stated in the finished-product specification.
Adrenosem Veterinary Grade API differs from other hemostatic agents in both mechanism and clinical boundary. Tranexamic acid and aminocaproic acid act as plasminogen-binding inhibitors and are used to stabilize fibrin once formed; vitamin K is a cofactor for hepatic synthesis of factors II, VII, IX, and X. Carbazochrome salicylate neither inhibits plasminogen activation nor supplies coagulation-factor cofactors. Instead, it reduces capillary permeability and increases capillary resistance, limiting microvascular oozing. This distinction has two consequences. First, the API is not a substitute for antifibrinolytics, vitamin K, fresh frozen plasma, or platelet-rich products in animals with coagulopathic bleeding. Second, it can be combined with other hemostatic measures only when the bleeding source is capillary and the treating veterinarian has excluded systemic clotting defects. The table below summarizes the operative differences; product selection should follow a differential diagnosis of the bleeding source rather than a class substitution.
| Agent or class | Principal mechanism | Limitation relevant to veterinary hemostasis |
|---|---|---|
| Carbazochrome salicylate | Capillary stabilization; reduced capillary permeability | Not effective for arterial hemorrhage or fibrin clot deficiency |
| Tranexamic acid | Inhibits plasminogen activation | Does not correct thrombocytopenia or surgical vessel rupture; does not act on capillary fragility |
| Aminocaproic acid | Inhibits plasminogen activation | Does not act on capillary fragility; requires adequate fibrin formation to be effective |
| Vitamin K | Cofactor for hepatic synthesis of factors II, VII, IX, X | Onset delayed; ineffective in hepatic failure or acute surgical bleeding |
| Ethamsylate | Capillary wall stabilization; platelet prostaglandin modulation | Mechanistic overlap but different chemical class; not a substitute for transfusion in thrombocytopenia |
For the veterinary prescriber, the key operational boundary is that Adrenosem-based products should be restricted to capillary oozing syndromes and should not be used as rescue therapy for major hemorrhage. If published hemostasis guidelines for a given target species are available, those recommendations take precedence over general pharmacologic class descriptions.
