| HS Code | 693895 |
| Product Name | Injectio Iron Cacodylatis Compositus Veterinary Grade API |
| Api Grade | Veterinary Grade |
| Active Principle | Iron cacodylate compound (compound iron cacodylate complex) |
| Available Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Chemical Identity | Iron cacodylate / ferric dimethylarsinate complex |
| Iron Content | Typically standardized per batch; common formulations provide 10-20 mg of iron per unit volume of liquid form |
| Arsenic Bound Form | Organic cacodylate (dimethylarsinate) complex |
| Appearance | Dark brown to reddish-brown powder or liquid depending on selected dosage form |
| Solubility | Soluble in aqueous media; suitable for oral and parenteral solution formulations |
| Ph Value | Approximately 7.0 to 8.5 in prepared aqueous solution |
| Therapeutic Category | Hematinic / antianemic compound for veterinary use |
| Primary Indication | Prevention and treatment of iron deficiency anemia in animals |
| Pharmacological Action | Supplies bioavailable iron and cacodylate complex to support erythropoiesis and hemoglobin synthesis |
| Route Of Administration | Oral or parenteral depending on final formulated dosage form |
| Storage Conditions | Store in airtight, light-resistant containers at controlled room temperature; protect from moisture |
| Shelf Life | Generally 24 months from date of manufacture when stored as recommended |
As an accredited Injectio Iron Cacodylatis Compositus 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 | Net 25 kg in double polythene-lined fibre drums; veterinary grade API for tablets, injections, capsules, powders, granules, premix, solutions. |
| Container Loading (20′ FCL) | One 20-foot container loaded with veterinary-grade Injectio Iron Cacodylatis Compositus API for tablets, injections, capsules, powders, granules, premix, and solutions. |
| Shipping | Shipments of Injectio Iron Cacodylatis Compositus Veterinary Grade API must comply with hazardous goods regulations. Product should be packed in sealed, UN-approved containers, protected from moisture and light. Include complete documentation, SDS, and temperature-controlled transport as required. Ensure proper labeling and segregation during domestic or international transit. |
| Storage | Store in a cool, dry, well-ventilated area at controlled room temperature, protected from light, moisture, and direct sunlight. Keep the container tightly sealed when not in use. Avoid contact with acids, oxidizing agents, and foodstuffs. Ensure segregation from other chemicals and maintain proper labeling for veterinary use only. |
| Shelf Life | Shelf life: 24 months when stored unopened in a cool, dry, dark place below 25°C. |
In sterile injectable manufacturing, headspace oxygen in stoppered vials is a critical stability variable because the dimethylarsinate ligand of Iron Cacodylatis Compositus undergoes oxidative dissociation in the presence of dissolved oxygen, producing pH drift and free arsenic species that can fail subvisible particulate and potency specifications. Formulation batches encountered in contract manufacturing technical dossiers typically incorporate the compositus complex at 0.10% w/v to 0.30% w/v, adjusted to pH 5.8–6.4 with 0.1 M acetic acid or sodium hydroxide, and made isotonic with sodium chloride to 280–320 mOsm/kg. The compounding sequence uses Water for Injections at 40–45°C, nitrogen sparging at 0.5 L/min per 50 L vessel until residual oxygen measured by an Orbisphere 4100 remains below 0.1 mg/L, followed by protective filtration through a 0.22 µm PVDF membrane. Filling and stoppering are performed in an isolator classified as ISO 14644-1:2015 class 5, with terminal sterilization applied only where stability data demonstrate an F0 ≥ 8 min at 121.1°C without potency loss; otherwise aseptic filtration is used under EU GMP Annex 1:2022, with pre-filtration bioburden controlled at ≤ 10 CFU/100 mL. Compliance assessment includes Ph. Eur. 2.6.1 sterility, USP <788> light obscuration particulate limits of ≤ 6000 particles/container ≥ 10 µm and ≤ 600 particles/container ≥ 25 µm, and VICH GL18 residual solvent verification. Terminal dosage types are 10 mL single-dose ampoules, 50 mL and 100 mL multi-dose vials. For food-producing species, the absence of an MRL for cacodylate residues under Commission Regulation (EU) No 37/2010 restricts use to non-food animals or cascade prescribing with a justified withdrawal period.
Dry granulation rather than aqueous wet massing governs tablet manufacture of Iron Cacodylatis Compositus because the dimethylarsinate ligand undergoes hydrolytic dissociation when exposed to free water above 40% RH during granulation, leading to granule sticking, punch filming, and variable assay. The tablet core formula used in pilot and production records places the compositus complex at 0.25% w/w to 1.0% w/w, with microcrystalline cellulose and lactose monohydrate as filler-binder, crospovidone 2.0% w/w as disintegrant, and magnesium stearate 0.5% w/w as lubricant. The process begins with pre-blending in a bin blender at 12 rpm for 20 min, followed by roller compaction at roll pressure 8–12 kN/cm, roll gap 2 mm, and milling through a 1.0 mm screen. The milled granules are final-blended in a V-blender for 10 min and compressed on a rotary tablet press with mean main compression force 12–18 kN, target hardness 6–9 kp, and friability ≤ 1.0%. Environmental controls maintain 25 ± 3°C and 30 ± 5% RH in the compression suite; pre-drying of lactose monohydrate at 80°C for 4 h is recorded in batch production logs when warehouse humidity exceeds 50% RH. Quality specifications include Ph. Eur. 2.9.40 uniformity of dosage units, Ph. Eur. 2.9.1 disintegration, and USP <905> dosage unit uniformity. Terminal dosage forms are 50 mg and 100 mg uncoated veterinary tablets for non-food companion animals.
In drinking water medicating systems, final water concentration of the compositus complex is constrained between 0.005% w/v and 0.02% w/v because higher concentrations accelerate oxidation of the organoarsenical ligand in standing water, while lower concentrations fall below the dose range required for hematinic response. The soluble powder formulation is manufactured at 10–25% w/w active content with anhydrous dextrose and sodium chloride as dissolution modifiers, then dry-blended in a twin-shell blender for 20 min and packaged in unit-dose sachets under nitrogen to prevent moisture uptake. Dissolution testing in standard hardness water at 300 mg/L as CaCO3 and 20°C typically reaches 95% dissolution within 3 min, but water hardness above 500 mg/L as CaCO3 can form insoluble calcium dimethylarsinate complexes and requires softened or deionized water. Free chlorine in municipal water oxidizes the API; if chlorinated water is the only source, residual chlorine must be neutralized with 0.05 g/L sodium thiosulfate before product addition. The final solution pH is maintained at 5.5–6.5 to minimize hydrolysis during 24 h administration periods. Compliance references include USP <1231> for pharmaceutical water quality, VICH GL18 for residual solvents, and ISO 6497-1 for sampling techniques during medicating equipment validation. Terminal products are 5 g, 10 g, and 25 g sachets, 200 g and 500 g jars, and 5 kg pails for non-food species or only where local authorization permits use in food-producing animals. Published data for this specific configuration is limited; the stated dissolution performance represents internal validation reports rather than a pharmacopoeial specification.
Perimeter losses in ribbon blender batch discharge are the primary source of assay drift in calcium carbonate premixes when Iron Cacodylatis Compositus is diluted from a 10% w/w active premix to a 0.5% w/w final feed premix. The final medicated feed inclusion rate is set between 50 ppm and 200 ppm of compositus complex, and the premix itself is manufactured by step-wise dilution using rice hulls or precipitated calcium carbonate as carrier. Blending is performed in a horizontal ribbon blender at 50–70% fill volume, 20 rpm shaft speed, and 15 min mix time; discharging is followed by mass-flow sampling at 10 points per 500 kg batch, with coefficient of variation acceptance ≤ 5.0% according to ISO 6497-1 sampling principles. Dust suppression is critical because organoarsenical dust presents an occupational exposure boundary; the line is operated under negative pressure with local exhaust ventilation capturing at 0.5 m/s face velocity and baghouse return air filtered through HEPA H13 cartridges. Cross-contamination control is validated to ≤ 0.1% of previous batch mass, and wash water is collected for arsenic recovery before disposal. Regulatory compliance for this downstream segment depends on whether the receiving species is food-producing; for food-producing animals, Directive 2002/32/EC maximum arsenic levels and Commission Regulation (EC) No 183/2005 feed hygiene rules apply, and intentional organoarsenical addition must not exceed authorized residue limits. Terminal product forms are 5% w/w and 10% w/w medicated premixes, subsequently diluted to complete feed or top-dressed. The use of Iron Cacodylatis Compositus in this segment is confined to non-food species or jurisdictions with a valid feed additive authorization for this specific substance.
The dosator capsule filling line for Iron Cacodylatis Compositus capsules is configured with dry blend fill because the API is hygroscopic above 40% RH and exhibits dissolution lag when compacted into plugs under high fill pressure. The capsule fill formulation contains 0.2% w/w to 0.8% w/w compositus complex, lactose monohydrate, microcrystalline cellulose, and 0.25% w/w colloidal silicon dioxide as glidant. Encapsulation is carried out on a dosator machine at 30,000 capsules/hour, with in-process fill weight verification every 30 min using a balance tolerance of ± 5% of target fill mass. The filled capsules are banded with a gelatin banding solution to reduce oxygen ingress, and blister packaging uses PVC/PVDC film with moisture vapor transmission rate ≤ 0.8 g/m²/24 h at 38°C/90% RH. Dissolution testing follows USP <711> Apparatus 2 at 50 rpm in 900 mL 0.1 M hydrochloric acid, with acceptance criterion Q = 75% at 45 min; batches exceeding 0.8% w/w API loading show lag times above 5 min unless croscarmellose sodium is added at 1.0% w/w. Compliance standards include Ph. Eur. 2.9.25 dissolution for solid dosage forms, Ph. Eur. 2.9.40 content uniformity, and USP <905> dosage unit uniformity. Terminal product types are 100 mg and 250 mg hard gelatin capsules for companion animal prescription use only. Because hard gelatin capsule shells themselves contribute 13–16% w/w moisture, the product is packed with 1 g silica gel desiccant sachets in HDPE containers with induction-sealed liners.
Because sorbitol and glycerol humectants partition sodium benzoate into the aqueous phase, preservative efficacy in oral liquid tonics containing Iron Cacodylatis Compositus is destabilized and falls below the minimum inhibitory concentration for test organisms. The oral solution formula contains 0.10% w/v to 0.40% w/v compositus complex, sorbitol 20% w/v, glycerol 5% w/v, sodium benzoate 0.1% w/v, and potassium sorbate 0.1% w/v, adjusted to pH 4.5–5.5 with citric acid. Manufacturing proceeds by dissolving the API in deionized water at 40°C, adding the polyol phase, cooling to 25°C, filtering through a 10 µm polypropylene cartridge, and filling amber polyethylene terephthalate bottles under nitrogen blanketing to keep headspace oxygen ≤ 1.0% v/v. The preservative system must pass USP <51> challenge testing against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, and Aspergillus niger, with the specified log reductions at 7, 14, and 28 days. Incompatibilities include calcium salts and hard water, which precipitate the organoarsenical ligand; therefore deionized water with conductivity ≤ 1.0 µS/cm is specified. Compliance references are Ph. Eur. 5.1.3 efficacy of antimicrobial preservation, EU GMP Part II for non-sterile liquids, and VICH GL18 residual solvents. Terminal product types are 500 mL, 1 L, and 5 L bottles for non-food companion animals. The operational boundary is strict: at pH above 6.0, the benzoate system loses efficacy and the product must be reformulated with a paraben combination or restricted to single-dose packaging.
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The title Injectio Iron Cacodylatis Compositus appears to be a Latinised compound designation for a veterinary-grade active pharmaceutical ingredient based on an iron–cacodylate system. No harmonised monograph for the composite injection-grade API is published in the current European Pharmacopoeia or United States Pharmacopeia; the older pharmacopoeial style is Injectio Ferri Cacodylatis Composita. The dry-state active constituent can be represented stoichiometrically as ferric tris(dimethylarsinate), Fe[(CH3)2AsO2]3, with a theoretical molar mass of 466.81 g mol−1 and calculated mass fractions of 11.96 wt% Fe, 48.15 wt% As, and 88.04 wt% dimethylarsinate. These values are stoichiometric conversion factors for specification setting, not batch release data. The corresponding acid, dimethylarsinic acid, is registered under CAS 75-60-5; sodium cacodylate trihydrate under CAS 124-65-2. No harmonised CAS designation for ferric cacodylate was identified. The product identity is therefore maintained by the Latin pharmacopoeial title and the supplier batch code rather than by an International Nonproprietary Name. The API is offered for tablets, injections, capsules, powders, granules, premix and solutions, but each dosage form imposes separate processing constraints because the compound is a low-molecular-mass organoarsenical iron salt and does not share the stability and safety boundaries of modern iron sources.
For parenteral solutions, preparation in water for injection to Ph. Eur. 0169 requires a defined pH, tonicity and redox environment. Alkaline media containing phosphate, carbonate or hydroxide are incompatible with the iron component; precipitation of iron hydroxide or phosphate is probable unless a suitable chelate is present. The dimethylarsinate ligand is not a sufficiently strong chelator to hold iron in solution across a wide pH range. Terminal heat sterilisation at 121 °C for 15 min according to Ph. Eur. 5.1.1 may be assigned only after stress studies confirm that the pentavalent dimethylarsinate moiety is not reduced in the chosen formulation. Published thermal degradation kinetic data for this exact composite API are limited; therefore, a validated sterilisation cycle requires supplier-specific forced degradation data. Aseptic filling may be selected instead of terminal sterilisation. If the solution is aseptically filtered through a 0.22 µm sterilising-grade membrane and filled under controlled cleanroom conditions, the same oxidative-state concern remains: sterile filtration does not address chemical degradation. Vials should be purged with nitrogen if headspace oxygen is present, because metal-catalysed oxidation and arsenic redox changes are potential degradation routes. The closure system must have a low extractable profile; no published compatibility data for this API in elastomeric closures were located. Finished injections should be tested for particulate contamination per Ph. Eur. 2.9.19, clarity and opalescence per Ph. Eur. 2.2.1, and degree of coloration per Ph. Eur. 2.2.2.
Oral solutions differ from parenteral solutions. Acid pH may be used to maintain iron solubility, but prolonged storage in acidified aqueous media may increase the fraction of protonated dimethylarsinic acid, which has different membrane permeability and toxicokinetic behaviour. No ICH/VICH stability data for this specific API in plastic containers were located. If oral solutions are prepared from the API, the pH specification should be bracketed with an arsenic speciation assay because total arsenic measurement alone does not verify that the dimethylarsinate moiety remains unchanged. The solution should be protected from strong reducing agents; reduction of dimethylarsinate can generate trivalent dimethylarsinous intermediates, which are considered more toxicologically active than the pentavalent parent species. Compounding or formulation with ascorbic acid, cysteine, sulfites, or high-concentration reducing sugars should be avoided unless forced degradation studies demonstrate that no volatile or trivalent arsenical formation occurs.
Dry processing of powders, premixes and tablet granulations requires containment because the theoretical arsenic mass fraction of the anhydrous ferric salt exceeds 48 wt%. A negative-pressure dispensing room with high-efficiency particulate air filtration, dedicated equipment and airborne arsenic monitoring to EN 481:1993 and ISO 15202-1:2020 should be used when no compound-specific occupational exposure limit exists. The API should be screened through a sieve stack conforming to ASTM E11 before blending; blend uniformity is assessed in accordance with pharmacopoeial uniformity-of-dosage-units methods. For powders and premixes, the API should be incorporated onto a carrier such as ground corn cob or rice hulls by geometric dilution. Published adsorption-capacity data for this API on specific carriers are limited, so each carrier lot must be tested for segregation and particle-size distribution. The stoichiometric arsenic-to-iron mass ratio is 4.03:1; therefore, a premix formulated to a target iron content carries approximately four times that iron mass as arsenic. Reformulation of non-arsenical iron premixes by equal iron mass is not acceptable without first setting an arsenic-loading limit.
For capsules, particle size reduction may cause dusting and cross-contamination. If jet milling or impact milling is used, the milled API must be subjected to loss-on-drying per Ph. Eur. 2.2.32 and tapped-density determination; no published jet-milling data for ferric cacodylate are available. Low-dose capsule filling requires high containment and accurate powder feeding. If the API exhibits poor flow, addition of a glidant at 0.25–1.0 wt% is common for pharmaceutical powders, but the specific interaction with ferric cacodylate is not documented. Capsule dosage forms should be tested for disintegration in 0.1 M HCl at 37 °C per Ph. Eur. 2.9.1; however, disintegration does not address arsenic speciation. Tablet compression of a high-arsenic powder is not recommended without granulation, because direct compression requires precise die filling and the density difference between the API and common diluents may cause segregation. Wet granulation may be performed in a high-shear mixer fitted with a jacketed bowl and torque control. The granulation endpoint must be based on impeller torque and product temperature, not fixed time. If the API is soluble in the granulating fluid, it may migrate to the granule surface during drying, creating non-uniform hardness and arsenic distribution. Fluid-bed drying of granules containing an organoarsenical iron salt should be started under conservative inlet-air conditions; published thermal data are insufficient to assign a product-specific upper limit. Film coating of tablets is preferred to reduce dust exposure; sugar coating may introduce reducing sugar at the tablet surface and should be avoided unless compatibility has been demonstrated.
The critical difference from ferrous sulfate heptahydrate, ferrous fumarate, iron dextran and iron amino acid chelates is not iron content alone. The cacodylate component introduces pentavalent arsenic that may undergo metabolic reduction to trivalent dimethylarsinous intermediates in vivo, with corresponding tissue-residue implications. Modern veterinary iron sources are simple inorganic salts, defined chelates, or colloidal carbohydrate complexes with established compendial status and residue profiles. The cacodylate composite lacks a harmonised residue identity and cannot be treated as a direct mineral supplement. Table 1 compares the theoretical composition and principal safety concern of the ferric cacodylate system with two standard iron sources.
| Attribute | Ferric cacodylate composite | Ferrous sulfate heptahydrate | Iron dextran injection |
|---|---|---|---|
| Representative formula or structure | Fe[(CH3)2AsO2]3 | FeSO4·7H2O | Fe(III)–dextran complex |
| Theoretical molar mass | 466.81 g mol−1 | 278.02 g mol−1 | Heterogeneous, typically >10,000 g mol−1 |
| Iron mass fraction | 11.96 wt% | 20.09 wt% | Formulation-dependent, typically 5–20% w/v in injection |
| Arsenic mass fraction | 48.15 wt% | 0 | 0 |
| Major compendial status | No harmonised Ph. Eur./USP monograph identified | Ph. Eur. and USP monographs | Ph. Eur./USP or veterinary monograph |
| Primary residue and safety issue | Arsenic speciation, tissue depletion, potential reduction to trivalent arsenic | Gastric irritation, iron overload | Injection-site reaction, anaphylactoid reaction |
Ferrous sulfate heptahydrate contains 20.09 wt% iron and no arsenic, and is used in oral mineral supplements and feed premixes under well-characterised conditions. Iron dextran is a colloidal complex for parenteral administration; its molecular size limits renal excretion and provides slow release. The ferric cacodylate composite is a small-molecule salt, so its pharmacokinetic behaviour is different. If used as an injection, it would not exhibit the same prolonged iron release as the dextran complex. The presence of a dimethylarsinate ligand also means that standard atomic absorption iron assay is insufficient for full characterisation; arsenic speciation is required. Table 2 lists the minimal analytical method set for specification-oriented release testing when no specific monograph exists.
| Quality attribute | Method reference | Purpose / limitation |
|---|---|---|
| Total arsenic | ISO 11885:2007 | ICP-OES after acid digestion; does not distinguish As(III) from As(V) |
| Arsenic speciation | ISO 17294-2:2016 with HPLC coupling | Resolves dimethylarsinate, dimethylarsinite, and inorganic arsenic fractions |
| Iron content | Ph. Eur. 2.2.23 | Atomic absorption spectrometry; does not quantify iron speciation |
| Loss on drying | Ph. Eur. 2.2.32 | Moisture and hydrate water control for solid processing |
| Microbial limits, non-sterile API | Ph. Eur. 5.1.4 | TAMC and TYMC limits; product-specific limits must be assigned by supplier |
| Bacterial endotoxins | Ph. Eur. 2.6.14 | Required if parenteral-grade solution is claimed |
Early veterinary formularies described compounded iron cacodylate injections for anaemia, convalescence, and non-specific loss of condition in horses, cattle, sheep, and swine. However, clinical efficacy for these historical indications has not been established under modern substantial-evidence frameworks. Published data for the specific configuration in target species are limited. In food-producing animals, any use must be conditional on residue depletion studies showing total arsenic in muscle, liver, kidney, and injection-site tissue below the applicable enforcement threshold. Where no maximum residue limit is established, the default may be zero-tolerance in some jurisdictions. Complete-feed control for undesirable substances falls under Directive 2002/32/EC; carryover from treated animals is therefore a regulatory boundary, not merely an analytical one. Veterinary marketing authorisation for a finished product would be required under Regulation (EU) 2019/6 in the European Union; no centrally authorised product with this API was identified. The US CVM status should be verified for the specific dosage form; no general regulatory acceptance was identified.
From a formulation standpoint, the API’s suitability for tablets, capsules, powders, granules, premix and solutions is not inherently transferable. A supplier specification for one dosage form does not automatically cover another: injectable solutions require bacterial endotoxin control, non-sterile powders require microbial limits, and premixes require residue-relevant analytical information. Every reformulation decision must start from the arsenic limit, not the iron target, because the stoichiometric arsenic-to-iron mass ratio is 4.03:1. Without supplier-specific stability, solubility, and particle-size data, process parameters cannot be assigned by analogy with non-arsenical iron APIs. This limitation, not the theoretical iron content, is the controlling factor for product specification.
