| HS Code | 891699 |
| Product Name | Iron Dextran 20% Pharma Grade API for Tablet/Capsule/Granule/Injection |
| Active Pharmaceutical Ingredient | Iron Dextran |
| Cas Number | 9004-66-4 |
| Grade | Pharma Grade |
| Concentration | 20% |
| Iron Content | 20% elemental iron |
| Physical Form | Dark brown to brownish-black amorphous powder or granules |
| Solubility | Freely soluble in water forming a dark brown colloidal solution; practically insoluble in ethanol and most organic solvents |
| Ph Value | 5.0 to 7.0 in aqueous solution |
| Average Molecular Weight | Approximately 165,000 Da |
| Compatible Dosage Forms | Tablet, Capsule, Granule, Injection |
| Administration Routes | Oral, Injectable |
| Chemical Family | Ferric hydroxide-dextran macromolecular complex |
As an accredited Iron dextran 20% Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Iron Dextran 20% Pharma Grade API supplied in 25 kg drums, suitable for oral and injectable dosage forms. |
| Container Loading (20′ FCL) | 20′ FCL loaded with palletized drums of Iron Dextran 20% Pharma Grade API, secured for oral and injectable pharmaceutical use. |
| Shipping | Iron dextran 20% Pharma Grade API ships in sealed, moisture-proof drums or containers to preserve stability and purity. Transport requires temperature-controlled, dry conditions, away from sunlight. Proper labeling as pharmaceutical raw material is essential. Ensure compliance with local and international hazardous/non-hazardous shipping regulations, with tamper-evident packaging for safe handling and delivery. |
| Storage | Store Iron Dextran 20% Pharma Grade API in a cool, dry, well-ventilated area at controlled room temperature, preferably below 25°C. Keep tightly sealed in its original container, protected from light, moisture, and direct heat. Avoid prolonged exposure to air. Ensure the area is clean and free from incompatible substances to maintain stability and purity. |
| Shelf Life | Shelf life is typically 24 months from date of manufacture when stored unopened in a cool, dry place. |
In oral immediate-release iron replacement tablet manufacturing, the arithmetic of the 20% w/w elemental iron content controls the entire formulation. A 100 mg elemental iron label claim requires 500 mg of iron dextran complex; at a target core weight of 850 mg, the API mass fraction is 58.8% w/w. Direct compression is not a viable default because the hygroscopic complex exhibits punch filming and capping at compression forces above approximately 12 kN when the API fraction exceeds 50% w/w. Published data for this specific complex in direct compression is limited, so the production route is typically wet granulation. The complex is granulated in a high-shear mixer with pregelatinized starch or copovidone binder solution; the wet mass is discharged at a motor amperage endpoint equivalent to 15–25 Nm torque, then dried in a fluid-bed dryer with inlet air at 60 °C and product temperature not exceeding 40 °C to avoid dextran browning. Dried granules are milled through a 1.0 mm screen, blended with microcrystalline cellulose, croscarmellose sodium, and magnesium stearate in a bin blender, and compressed on a rotary press with 10–20 kN compression force to a hardness of 80–120 N measured under USP 1217. Compliance for this pathway is anchored to USP 905 Uniformity of Dosage Units, USP 701 Disintegration and USP 711 Dissolution, with release testing for elemental iron by acid digestion followed by atomic absorption or ICP-OES. Elemental impurity risk is assessed against ICH Q3D; residual solvents are controlled under ICH Q3C. Manufacturing operations fall under 21 CFR 211, and the API itself is manufactured under ICH Q7. Terminal finished product types are immediate-release film-coated tablets in 50 mg or 100 mg elemental iron strengths; film coating serves primarily to mask surface staining and to reduce contact staining on packaging equipment. At relative humidity above 60%, the uncoated core can absorb moisture and weaken hardness; therefore coated tablets are packed with desiccant and aluminum foil blisters. Cleaning validation on contact surfaces uses swab sampling for iron residues with confirmation by ICP-MS; cleaning agents based on strongly oxidizing acids are avoided because they degrade the dextran component and may generate free iron residues.
Direct encapsulation of the as-received iron dextran 20% complex in hard gelatin or HPMC capsules is constrained by bulk density and moisture sensitivity. For a 50 mg elemental iron capsule, the required complex mass is 250 mg. In a 400 mg total fill weight, the API mass fraction is 62.5% w/w, leaving only 37.5% w/w for fillers, disintegrant, and lubricant. The complex is pre-dried at 50 °C for 2–4 h if loss-on-drying exceeds 3.0% w/w, and the powder is then passed through a 0.8 mm screen before blending. Low-shear V-blender or bin blending is used for 15–20 min; magnesium stearate is added at 0.5–1.0% w/w in the final 3 min to avoid hydrophobic over-lubrication. Capsule filling on a dosator-type machine requires controlled powder bed height and relative humidity below 40% RH; tamping pin fillers are less preferred because the compacted slug can adhere to pins and cause weight variation exceeding the acceptance value under USP 905. Blend uniformity is monitored by near-infrared spectroscopy calibrated against ICP-OES at the target iron concentration; sampling locations include dead spots below the V-blender trunnion. Dissolution testing under USP 711 uses 0.1 N hydrochloric acid medium at 37 ± 0.5 °C with basket or paddle apparatus. Disintegration is evaluated under USP 701. Compliance also includes ICH Q3D elemental impurity risk assessment and 21 CFR 211 finished pharmaceutical GMP; the API must be accompanied by residual solvent data under ICH Q3C. Finished dosage forms are hard gelatin capsules or HPMC capsules containing 50 mg elemental iron per unit, packed in PVC/PVdC or cold-form aluminum blisters with desiccant. The main operational boundary is moisture: at storage above 60% RH the capsule shell softens and the fill may darken from iron oxidation, so desiccant loading is calculated based on moisture vapor transmission rate of the blister material.
When pediatric and geriatric dose titration requires oral granule sachets rather than tablets, the 20% w/w complex is wet-granulated to improve reconstitution and reduce dust deposition on contact surfaces. A 20 mg elemental iron unit-dose sachet requires 100 mg of iron dextran 20% complex; at a total filled granule mass of 500 mg, the API mass fraction is 20.0% w/w. A 100 mg elemental iron sachet requires 500 mg complex, and the total fill mass rises to 1000 mg if the API fraction is held at 50.0% w/w. The production process uses top-spray fluid-bed granulation with an aqueous binder solution of maltodextrin or hydroxypropyl cellulose; spray rate is adjusted to maintain product bed temperature at 30–35 °C and outlet relative humidity below 50% to prevent overwetting and agglomeration. After drying, granules are sieved to 0.355–0.850 mm; over- and under-sized fractions are milled and recycled. Extragranular components such as silicon dioxide and sodium stearyl fumarate are blended before filling in stick-pack or sachet machines with auger metering. The final blend is filled on vertical form-fill-seal stick-pack lines with auger metering; because the granules are dark and iron-rich, stainless steel contact parts require manual wipe-down every 4 h to prevent buildup that affects fill weight. Compliance for oral granules includes USP 905 for unit-dose uniformity, USP 786 for particle size distribution by analytical sieving, and USP 711 dissolution where the product is intended for suspension and immediate release. Taste-masking is required because the complex imparts a metallic taste; fluid-bed polymer layering with ethylcellulose or polyvinyl acetate is applied before final blending, and the coating level is confirmed by dissolution testing. Finished products are unit-dose oral granules in sachets or stick packs in 20 mg, 50 mg, and 100 mg elemental iron strengths, intended for sprinkling on soft food or for reconstitution in water. The operation boundary is the dextran thermal sensitivity; fluid-bed inlet air above 70 °C can darken the granule surface and reduce dissolution.
| Target product | Elemental iron per unit | Iron dextran 20% complex mass | Total unit core/fill mass | API mass fraction |
|---|---|---|---|---|
| Film-coated tablet | 100 mg | 500 mg | 850 mg | 58.8% w/w |
| Hard capsule | 50 mg | 250 mg | 400 mg | 62.5% w/w |
| Oral granule sachet | 20 mg | 100 mg | 500 mg | 20.0% w/w |
| Oral granule sachet | 100 mg | 500 mg | 1000 mg | 50.0% w/w |
The transition from dry powder processing to aqueous injectable formulation changes the risk profile from compressibility and moisture to free iron, pH drift, and particulate aggregation. For a human parenteral product at 50 mg elemental iron per mL, each litre of final solution requires 250 g of iron dextran 20% complex. A 1000 L production batch therefore requires 250 kg API, with assay adjustment based on the certificate of analysis iron content. The complex is dissolved in Water for Injection at 25–35 °C under low-shear propeller agitation; pH is adjusted to 5.2–6.5 with hydrochloric acid or sodium hydroxide. Nitrogen sparging is applied to reduce oxidative degradation of the dextran moiety. Sterilizing-grade membrane filtration is generally unsuitable because the colloidal iron-dextran aggregates can blind the membrane or remove active fraction; the formulation is therefore filled into Type I glass vials and terminally sterilized by steam at 121 °C for 15 min, with product-specific validation of the F0 value. A small-scale thermal stability matrix is performed before production to confirm that pH and free iron remain within release limits after terminal sterilization; batches showing visible precipitation are not reworked. Post-autoclave pH and free iron are critical in-process checks; an increase in free iron above the release limit indicates insufficient complexation or thermal stress and requires batch rejection. Subvisible particulate matter is controlled under USP 788 for small-volume injections: not more than 6000 particles ≥10 µm and not more than 600 particles ≥25 µm per container. Visible particulates are controlled under USP 790. Bacterial endotoxins are controlled under USP 85, and sterility is confirmed under USP 71. The manufacturing line uses ceramic or plastic-wetted parts on filling pumps to minimize metal staining and abrasion. Terminal finished product types are 2 mL single-use vials delivering 100 mg elemental iron (50 mg/mL), and 5 mL single-use vials delivering 250 mg elemental iron, for intravenous or intramuscular administration under physician supervision. Published data for specific foaming and viscosity at production scale is limited; however, excessive agitator tip speed above approximately 3 m/s can introduce air bubbles that persist in the colloidal solution and interfere with filling volume accuracy.
In veterinary farrowing-unit iron supplementation, iron dextran 20% complex is formulated as a 200 mg elemental iron per mL injectable solution. A 1000 L batch requires 1000 kg of the 20% complex, producing a high-viscosity dark brown liquid that behaves as a non-Newtonian colloid. Downstream processing uses a jacketed dissolution vessel at 30–35 °C with low-shear mixing; pH is adjusted to 5.2–6.5 before the batch is transferred through pre-filtration with a 5 µm polypropylene depth filter to remove undissolved gel particles. Terminal steam sterilization at 121 °C for 15 min must be adjusted based on container heat penetration; cold-spot F0 values for 100 mL and 200 mL multidose vials are recorded and release is conditional on meeting the validated F0 requirement. After autoclaving, free iron is measured by a validated colorimetric method, and visible particles are controlled under USP 790 with subvisible particles controlled under USP 788. Residual solvents are controlled under VICH GL18(R2); GMP for the finished veterinary parenteral is under 21 CFR 211. Piston-type filling pumps with ceramic cylinders are used because rotary lobe or peristaltic filling can generate shear-induced aggregation. The terminal finished product types are 100 mL and 200 mL amber Type II glass vials or multilayer polypropylene bottles containing 200 mg/mL elemental iron, intended for intramuscular injection in piglets. The key operational boundary is autoclave residence time: excessive heat input increases free iron and darkens the solution; insufficient heat input fails sterility assurance. Batch-to-batch variation in the dextran molecular weight distribution can shift the post-autoclave viscosity and free iron profile, so the API specification must include intrinsic viscosity or gel permeation chromatography data.
| Application segment | Standards and compendial chapters | Critical control boundary |
|---|---|---|
| Oral tablets | USP 905, USP 701, USP 711, ICH Q3D, 21 CFR 211 | moisture ≤ 3.0% w/w; tablet hardness 80–120 N under USP 1217 |
| Oral capsules | USP 905, USP 701, USP 711, ICH Q3D, 21 CFR 211 | loss-on-drying ≤ 3.0% w/w; fill room RH < 40% |
| Oral granules | USP 905, USP 786, USP 711, ICH Q3D | fluid-bed inlet air ≤ 70 °C; granule sieve 0.355–0.850 mm |
| Human injectable | USP 1, USP 788, USP 790, USP 85, USP 71, 21 CFR 211 | pH 5.2–6.5; terminal sterilization 121 °C for 15 min |
| Veterinary injectable | USP 1, USP 788, USP 790, VICH GL18(R2), 21 CFR 211 | pH 5.2–6.5; post-autoclave free iron within validated limit |
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Iron dextran 20% Pharma Grade API is a dark brown, water-dispersible ferric oxyhydroxide–dextran complex supplied as a spray-dried powder for use in tablet, capsule, granule, and injectable manufacturing. The designation specifies elemental iron content of 20.0% w/w on the dried basis, not a simple dilution of ferric chloride. Because the iron is present as a carbohydrate-stabilized ferric complex rather than as free Fe²⁺, the API can be processed into oral solid-dose forms where immediate acid-mediated iron release is undesirable, as well as into injectable presentations after terminal sterilization or aseptic processing. The material is typically characterized by loss on drying ≤ 5.0%, a pH of 5.0–7.0 for a 10% aqueous dispersion, and a particle-size distribution with D90 ≤ 150 µm when tested by laser diffraction under USP <429>. These properties place the product between freely soluble ferrous salts and high-molecular-weight intravenous iron colloids.
Unlike ferrous sulfate heptahydrate, which releases ionized Fe²⁺ rapidly upon contact with gastric fluid, iron dextran presents iron as a colloidal ferric oxyhydroxide core surrounded by partially hydrolyzed dextran. The release mechanism is therefore acid-mediated decomplexation rather than simple dissolution. This structural difference changes the oral absorption profile and reduces the local free-iron burden in the gastric epithelium. Ferrous sulfate heptahydrate has an elemental iron content of approximately 20.1% w/w and a molecular weight of 278 g/mol, while the 20% iron dextran complex is a macromolecular colloid whose dextran fraction may vary by grade. In oral solid-dose development, the iron dextran complex requires a lower mass of the API to meet the same elemental iron target as ferrous sulfate heptahydrate only when the assay is identical; for example, 300 mg of 20% iron dextran API delivers 60 mg elemental iron on a dried basis. However, iron dextran is not freely water-soluble, so dissolution testing under USP <711> must be interpreted against a colloidal dispersion model rather than a simple solution model. Published data for this specific configuration is limited, and formulation-specific dissolution curves should be generated using the final tablet or capsule matrix.
The API release specification is organized around three control layers: chemical identity and assay, microbial and endotoxin burden, and physical properties relevant to solid-dose processing. For oral grades, iron content is standardized to 20.0% ± 1.0% w/w on the dried basis by redox titration after acid digestion. Chloride is generally controlled at ≤ 0.1%, and elemental impurities are aligned to ICH Q3D with a typical heavy-metals limit of ≤ 20 ppm. For injectable grades, bacterial endotoxin control is more stringent, with a common acceptance criterion of ≤ 0.5 EU/mg when assayed by USP <85>. The material is hygroscopic, and residual moisture above 5.0% w/w can reduce flow and promote particle aggregation during storage. Because the API is used in both oral and injectable routes, the manufacturer must segregate oral-grade and injectable-grade lots unless the entire process is validated to injectable-grade controls.
High-dose oral tablets containing iron dextran 20% generally require excipient optimization because the API alone often exhibits poor flow and high sensitivity to moisture. In production-scale trials, a 65 L high-shear granulator operating at impeller speed 120–180 rpm and chopper speed 1,500 rpm has been used to distribute the API in a microcrystalline cellulose NF and sodium starch glycolate NF matrix. Fluid-bed drying at inlet air temperature 55–65 °C and dew point ≤ 10 °C is then applied until loss on drying of the granulate is below 2.5% w/w. If direct compression is preferred, the API may be pre-blended with 1.0% colloidal silicon dioxide NF and 0.5% magnesium stearate NF; however, the latter should not be over-lubricated because excessive magnesium stearate can reduce tablet hardness below 60 N and increase disintegration time beyond 15 min. For roller compaction, a roll pressure range of 30–60 kN and a screen size of 1.0 mm is a representative processing window, but ribbon density and granulate fines must be evaluated per formulation. Capsule filling on a dosator-type machine may require a minimum bulk density of 0.35 g/cm³ and a compressibility index below 25 to maintain weight variation within USP <905> limits.
Injectables made from iron dextran 20% differ fundamentally from oral solid-dose applications because colloidal integrity, free iron content, and pyrogen control become critical quality attributes. The final injection is typically formulated to contain 50 mg/mL elemental iron, aligning with the USP Iron Dextran Injection monograph. The API is dispersed in Water for Injection at 20–25 °C under high-shear mixing, and pH is adjusted to 5.2–6.5 using hydrochloric acid or sodium hydroxide. Free iron in solution should remain below 0.5% of total iron because elevated free ferric ion can destabilize the colloid and increase the risk of adverse reactions. The manufacturing process must distinguish between terminally sterilized product and aseptic filtration; because the complex is colloidal, terminal sterilization at 121 °C for 15 min is often evaluated, but the choice depends on the thermal stability of the specific dextran fraction and the final container-closure system. Published data for this specific configuration is limited, and each injectable formulation must be validated for colloid size distribution after sterilization, using dynamic light scattering or equivalent particle-size methods.
Endotoxin control for injectable iron dextran is more challenging than for low-molecular-weight drug substances because the dextran and colloidal iron components can interfere with the Limulus amebocyte lysate reaction. USP <85> remains the reference test, but sample preparation often requires dilution with endotoxin-free water and pH adjustment to 6.0–8.0 to avoid false-negative results. A common acceptance criterion of ≤ 0.5 EU/mg is applied to the API when it is intended for injectable use. The free iron limit is equally critical: if free Fe³⁺ exceeds 0.5% of total iron, the injection may show increased particle aggregation, visible precipitation, and higher toxicity. In production, ultrafiltration or diafiltration may be used to remove low-molecular-weight iron species and control the molecular-weight distribution of the dextran fraction. The colloidal particle size after reconstitution is generally controlled below 200 nm, although published data for this specific configuration is limited and must be generated with the final formulation.
Differences from other iron products are most visible in the specification matrix. The table below summarizes representative release parameters for iron dextran 20% API, ferrous sulfate heptahydrate, and iron sucrose injection concentrate. Iron sucrose is included because it is another carbohydrate-stabilized ferric complex, but its API iron content and molecular-weight profile differ from iron dextran.
| Attribute | Iron dextran 20% API | Ferrous sulfate heptahydrate | Iron sucrose injection concentrate |
|---|---|---|---|
| Elemental iron content | 20.0% w/w on dried basis | ~ 20.1% w/w | 20 mg/mL elemental iron |
| Iron chemical form | Ferric oxyhydroxide–dextran complex | Ferrous sulfate salt | Ferric hydroxide–sucrose complex |
| Water behavior | Colloidal dispersion | Freely soluble | Colloidal solution |
| Primary routes | Oral solid and injectable | Oral solid and liquid | Intravenous |
| Free iron release | Acid-mediated decomplexation | Immediate Fe²⁺ release | Low free iron |
| Typical pH of solution/dispersion | 5.0–7.0 for 10% dispersion | Acidic | Neutral to weakly alkaline |
The following checklist aligns the product to compendial and regulatory test standards. Acceptance criteria are representative; the approved specification for a given marketed product is governed by the relevant pharmacopoeial monograph, marketing authorization, and process validation data.
| Parameter | Representative acceptance criterion | Test standard |
|---|---|---|
| Identification | Positive for iron and dextran | USP Iron Dextran Injection monograph |
| Iron content | 20.0% ± 1.0% w/w on dried basis | Redox titration; USP <221> |
| pH of 10% dispersion | 5.0–7.0 | USP <791> |
| Loss on drying | ≤ 5.0% w/w | USP <731> |
| Chloride | ≤ 0.1% | Titrimetric method |
| Heavy metals / elemental impurities | ≤ 20 ppm | USP <233> / ICH Q3D |
| Bacterial endotoxins (injectable) | ≤ 0.5 EU/mg | USP <85> |
| Microbial limits | TAMC ≤ 10³ CFU/g; TYMC ≤ 10² CFU/g | USP <61> / USP <62> |
| Particle size distribution | D90 ≤ 150 µm | Laser diffraction; USP <429> |
Because iron dextran 20% API contains a strongly colored iron complex, cross-contamination in multi-product tableting or granulation suites is detectable at low levels but difficult to remove once dried. Swab recovery studies should include a stainless-steel coupon with a surface area of 25 cm² and an extraction solvent that contains dilute hydrochloric acid to solubilize dried ferric residues. A residual iron limit of 10 ppm in the next product is a typical cleaning validation target, although the exact limit must be derived from the maximum allowable carryover for the lowest therapeutic dose of the next product. High-shear granulators, mill screens, and tablet press feed frames are the most likely locations for residue accumulation. Equipment cleaning should avoid strong alkaline detergents alone because iron dextran residues may precipitate under alkaline conditions and adhere more firmly to metal surfaces. After cleaning, visual inspection and conductivity or total organic carbon analysis of rinse water are not sufficient for iron dextran; specific iron analysis by atomic absorption or inductively coupled plasma mass spectrometry is required to confirm clearance to the pre-defined residual limit.
