| HS Code | 968700 |
| Chemicalname | Prednisone |
| Molecularformula | C21H26O5 |
| Molecularweight | 358.43 g/mol |
| Casnumber | 53-03-2 |
| Description | White or almost white crystalline powder, odorless or with a slight odor. |
| Solubility | Practically insoluble in water; sparingly soluble in ethanol; soluble in chloroform and dioxane. |
| Assay | 99.0% to 101.0% on dried basis |
| Residualsolvents | Complies with ICH Q3C limits |
| Storageconditions | Store in tightly closed containers, protected from light, at controlled room temperature 2-30°C |
| Suitabledosageforms | Tablets, capsules, injections, powders, granules, premixes, and solutions |
| Particlesize | D90 typically 50-150 µm adjustable by micronization |
As an accredited Prednisone 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, moisture-proof drums or bags, 25 kg net each, with tamper-evident seals for safe veterinary API handling. |
| Container Loading (20′ FCL) | Prednisone veterinary grade API is packed securely in drums/containers, loaded into a 20′ FCL, protected from moisture and contamination for safe transport. |
| Shipping | Prednisone Veterinary Grade API ships in sealed, moisture-resistant, light-protected drums or bags with tamper-evident seals. Transport is temperature-controlled via ground, air, or sea, accompanied by SDS, certificates of analysis, and customs documentation. Proper hazardous material handling and GMP-compliant packaging ensure safe, regulatory-approved delivery worldwide. |
| Storage | Store Prednisone Veterinary Grade API in tightly sealed, light-resistant containers, in a cool, dry, well-ventilated area at controlled room temperature (15–30°C). Protect from moisture, heat, and direct sunlight. Keep away from incompatible substances. Ensure container remains closed when not in use to maintain stability, quality, and shelf life. |
| Shelf Life | Prednisone Veterinary Grade API has a shelf life of 24 months when stored properly in sealed containers, protected from light, moisture, and heat. |
In low-dose veterinary prednisone tablets, direct compression is selected only when the API concentration is ≥ 2% w/w and the resulting blend exhibits a compressibility index below 20% and a Hausner ratio below 1.25; below 2% w/w, segregation in the feed hopper causes weight variation failure under USP <905>. A direct-compression formula for a 5 mg prednisone tablet typically contains prednisone USP micronized 3–8% w/w, microcrystalline cellulose 35–50% w/w, lactose monohydrate 30–45% w/w, croscarmellose sodium 2–4% w/w, colloidal silicon dioxide 0.2–0.8% w/w, and magnesium stearate 0.5–1.0% w/w; the API particle size is controlled at D90 ≤ 90 µm and D50 ≤ 20 µm, with the sieve cut above 150 µm eliminated to avoid blend segregation. Pre-blending is carried out in a bin blender at 10–15 rpm for 15–25 min without an intensifier bar, and lubrication with magnesium stearate is added for no more than 3–5 min at 5–10 rpm to avoid overlubrication and delayed dissolution. Rotary tablet presses equipped with B-tooling and a 12–20-station turret are operated with a force feeder at 20–40 rpm, precompression force 2–5 kN, main compression force 8–18 kN, and press speed 20–50 rpm; ejection force should remain below 500 N. Tablet hardness is maintained at 40–80 N as measured by USP <1217>, friability remains below 1.0% after 100 revolutions per USP <1216>, and disintegration completes within 15 min in 900 mL water at 37 ± 2 °C per USP <701>. Dissolution is evaluated using USP <711> Apparatus 2 at 50 rpm in 900 mL of 0.1 N HCl; a release criterion of Q = 75% at 45 min is generally justified by reference to the human prednisone tablet monograph, because published veterinary-specific dissolution data for this configuration is limited. The terminal product is an immediate-release tablet with a total weight of 100–250 mg, often scored for dose splitting in dogs, packaged in HDPE bottles with a desiccant and stored at 25 °C / 60% RH; under these conditions, the product is typically assigned a 24-month shelf-life if moisture permeability of the packaging is below 0.5 mg/day.
Sterile prednisone injectable suspensions require particle size reduction below D90 ≤ 5 µm because the API is practically insoluble in water, and terminal sterilization by autoclaving at 121 °C for 15 min can accelerate crystal growth and caking, so aseptic processing is generally selected. A suspension formula may contain prednisone USP micronized 2–10 mg/mL, sodium carboxymethylcellulose 0.5–1.0% w/v, polysorbate 80 0.1–0.3% w/v, sodium chloride 0.9% w/v, benzyl alcohol 0.9% v/v, and water for injection; the pH is adjusted to 5.0–6.0 with dilute hydrochloric acid or sodium hydroxide, and the compounding operation is conducted in an ISO 14644-1 Class 5 filling suite with unidirectional airflow.
Wet milling is performed on a recirculating bead mill or high-pressure homogenizer fitted with 0.3–0.5 mm zirconium oxide beads and operated at a tip speed of 6–12 m/s with the mill chamber cooled to 15–25 °C; the target particle size is D90 ≤ 5 µm and D50 ≤ 2 µm to ensure syringeability through a 21-gauge needle and reproducible withdrawal from a multi-dose vial. Viscosity is controlled between 20–80 mPa·s on a Brookfield rotational viscometer at 60 rpm using spindle LV3; below 20 mPa·s the suspension settles rapidly, and above 80 mPa·s injection force through a small needle becomes excessive. Filled vials are tested for sterility by USP <71>, bacterial endotoxins by USP <85> with a limit of 0.5 EU/mg of prednisone, particulate matter by USP <788>, and deliverable volume by USP <1>. The terminal product is a 10–50 mL multi-dose vial containing a white to off-white suspension that must be resuspended by gentle swirling for 30 s; the labelled storage condition is 2–8 °C, and the in-use period after first puncture is limited to 28 days to minimize preservative depletion and microbial ingress.
On tamping pin capsule fillers, low-dose prednisone blends are sensitive to powder bed shear and overlubrication because the API is present at low concentration and fill weights are small; therefore filler type determines the acceptable flow and compression properties. A capsule formula for a 2.5 mg prednisone product may contain prednisone USP micronized 1–3% w/w, lactose monohydrate 55–75% w/w, pregelatinized starch 10–20% w/w, croscarmellose sodium 2–5% w/w, colloidal silicon dioxide 0.2–1.0% w/w, and magnesium stearate 0.5–1.5% w/w. On tamping pin capsule fillers, the powder bed height is set at 8–15 mm, compression ratio at 1.5–2.0, and tamping force at 100–400 N; on dosator machines, the dosator bore diameter and powder bed density are more critical, and fill weight variation is measured across 50 capsules using USP <905> with an acceptance value below 15. Blend moisture is maintained below 2.0% and the filling room at 20–25 °C and 35–45% RH because hard gelatin capsules become brittle below 13% shell moisture and soften above 16%. The terminal product is a size 3–5 hard gelatin capsule with a fill weight of 100–250 mg, packaged in PVC/PVDC blisters, and dissolution is tested by USP <711> Apparatus 1 at 100 rpm in 900 mL water with Q = 75% at 45 min for immediate-release capsules.
Because prednisone oral powders and granules for companion animals are administered by mixing with food at doses of 0.5–2.0 mg/kg, the carrier system and geometric dilution sequence determine whether the assay across the sachet fill remains within 95–105% of label claim. A typical oral powder contains prednisone USP milled 0.1–1.0% w/w in lactose monohydrate or microcrystalline cellulose, with fumed silica 0.1–0.5% w/w as glidant; the carrier is screened through a 500 µm sieve, and the API is pre-blended with an equal weight of carrier for 10 min in a V-blender at 15–20 rpm. The mixture is geometrically diluted by doubling the carrier quantity at each step, with mixing for 10–20 min after each addition. When a granule presentation is specified, the blend is wet-granulated with an aqueous solution of povidone K-30 at 2–5% w/w in a high-shear granulator at impeller speed 200–400 rpm and chopper speed 1,500–2,500 rpm; the wet mass is dried in a fluid bed at 40–50 °C until loss on drying is below 2.0%, then sieved to 250–850 µm granules. The dried granules are filled into sachets by gravimetric fillers with a relative standard deviation below 2%, while volumetric machines require checkweighing at least every 10–15 min. Powder flow is assessed by USP <1174>; compressibility indices above 25% indicate additional glidant or granule size adjustment is required. The terminal product is a unit-dose sachet or multi-dose jar with a measuring scoop, labelled for anti-inflammatory or immunosuppressive use in dogs and cats only, with a prohibition against administration to food-producing animals.
Prednisone premix intended for homogeneous incorporation into companion animal feed is produced as an absorbed carrier blend or spray-dried granulate because the API is sensitive to heat and moisture during pelleted feed manufacturing. A premix formula may contain prednisone USP 0.1–1.0% w/w in corn starch, maltodextrin, or calcium silicate; the premix is mixed in a ribbon blender at 10–20 rpm for 20–30 min, and uniformity is confirmed by sampling 10 locations with assay acceptance of 90–110% of target. When the premix is added before pelleting, the feed mash passes through a conditioner at 70–85 °C with 15–18% added moisture and a retention time of 20–40 s, followed by pellet die temperatures that can reach 80–95 °C; under these conditions, prednisone potency loss is observed in the range of 5–15%, but published data for this specific formulation configuration is limited, so a forced degradation study at 70 °C / 75% RH for 7 days is required for site-specific validation. Post-pelleting liquid application, in which a prednisone suspension or solution is sprayed onto cooled pellets at 1–3% by weight through a rotary atomizer, reduces thermal exposure but creates a separate process bottleneck: the pellets must be dried at 40–50 °C to a final moisture below 12%, and the coating equipment must be cleaned to avoid drug carryover. Carryover limits for medicated feed are typically set at 1–3% of the active concentration of the subsequent batch, and cleaning validation is documented according to 21 CFR 225.65 and VICH GL11. The terminal product is a pelleted or extruded feed topper with a labelled prednisone concentration of 1–10 mg/kg feed, limited to non-food animals unless specific regulatory approval is obtained for an intended species.
When a prednisone oral liquid is required for veterinary patients, solubility is achieved through a co-solvent–cyclodextrin ternary system rather than pH adjustment alone, because the API is practically insoluble in water and lacks an ionisable centre that would improve solubility across the pH 3–7 range. A stable oral solution is typically prepared with ethanol 10–30% v/v, propylene glycol 10–20% v/v, purified water, and hydroxypropyl-β-cyclodextrin 1–5% w/v as an inclusion complexing agent; the prednisone concentration is maintained at 0.1–0.5 mg/mL. The manufacturing sequence dissolves prednisone in the co-solvent blend under agitation at 500–1,000 rpm for 30–60 min; the cyclodextrin solution is then added, the batch is brought to final volume with purified water, and the solution is filtered through a 0.45 µm membrane to remove undissolved particulates. Because prednisone is photolabile and subject to oxidative degradation, the solution is sparged with nitrogen to a dissolved oxygen level below 2 mg/L, and sodium metabisulfite 0.1% w/v is added as antioxidant; the liquid is filled into amber glass bottles with child-resistant closures. The terminal product is a multi-dose oral solution with a calibrated dropper or oral syringe, protected from light, stored at 15–30 °C, and assigned a shelf-life of 12–24 months following stability studies at 25 °C / 60% RH; pH is maintained between 4.0–6.0 to limit hydrolytic degradation of the corticosteroid nucleus.
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Prednisone Veterinary Grade API is a synthetic 11-keto corticosteroid supplied as a white to almost white crystalline powder in multiple controlled grades for formulation into tablets, injections, capsules, powders, granules, premixes, and solutions. The molecular formula is C21H26O5, the molecular weight is 358.43 g/mol, and the CAS registry number is 53-03-2. The substance is very slightly soluble in water, slightly soluble in alcohol, and soluble in chloroform and methylene chloride; the low aqueous solubility of the free base requires particle-size control for solid oral and suspension dosage forms. Supplier model designations are not harmonized across manufacturers but generally encode the downstream route, particle-size grade, microbial load, and sterility status: standard non-sterile powder, micronized suspension grade, low-endotoxin parenteral grade, and premix carrier blend. The pharmacopeial identity remains the same, but the physical and microbiological attributes are route-specific. Veterinary-grade status is not a pharmacopeial title; it denotes GMP API released for veterinary use under ICH Q7A, EU GMP Part II, and applicable VICH guidance. Veterinary-grade prednisone is distributed against a release specification typically aligned with the USP Prednisone monograph and the corresponding Ph.Eur. monograph, with additional vendor specifications for particle size, endotoxin, and residual process solvents.
For solid oral and premix grades, the release specification typically includes an assay range of 97.0%–102.0% on the dried basis, a loss-on-drying limit of ≤1.0%, residue on ignition ≤0.1%, and specific optical rotation between +167° and +175°, as described in the USP Prednisone monograph. Related-substances testing by HPLC is directed against the monographs; the reporting threshold for unknown impurities is commonly set at 0.10%, with total impurities controlled to the vendor's validated limit. Residual solvents must meet USP <467> and VICH GL18; Class I solvents such as benzene and carbon tetrachloride are not accepted. Water content is normally controlled below 1.0% for non-sterile grades because moisture above this limit accelerates hydrolytic and oxidative degradation of the dihydroxyketone side chain. For parenteral grades, bacterial endotoxin limits are assigned according to the maximum veterinary dose; a common supplier limit is ≤0.5 EU/mg, but the finished-product limit derives from USP <85> and the route-specific maximum dose per kg. Sterile grade additionally requires compliance with USP <71> and particulate matter limits in USP <788> when incorporated into injections. Particle-size D90 limits are not compendial but are established by the finished-product developer using laser diffraction under USP <429> to maintain content uniformity and syringeability.
Production-scale solid oral processing of prednisone is frequently shifted away from direct compression of as-received powder because the crystalline material can exhibit poor flow and low bulk density. A typical immediate-release tablet process uses high-shear wet granulation: prednisone is geometrically diluted with lactose monohydrate and microcrystalline cellulose, granulated with a binder solution in a high-shear granulator, dried in a fluid-bed dryer to a loss-on-drying value below 2.0%, and milled through a 0.8 mm screen. Direct compression is generally limited to low-dose formulas below 5% prednisone mass fraction, where the API is pre-dispersed in directly compressible spray-dried lactose and crospovidone. In such blends, the D90 of the prednisone input is typically held below 150 µm; coarser grades increase segregation risk and cause content-uniformity failures in long bin-blender transfers. Tablet hardness for immediate-release products is typically maintained at 40–80 N, with disintegration assessed by USP <701>. For hard gelatin capsules, a granulated or roller-compacted blend with good flow through an auger or dosator is used; fill weight variability is monitored to ±3% at speeds above 60,000 capsules/h. Powder and granule unit-dose packages are dry-blended or wet-granulated, with moisture controlled below 2.0% to preserve physical stability and minimize hydrolysis during shelf life.
Particle-size distribution controls dissolution rate, content uniformity, and physical suspension stability. For prednisone suspension injections, a micronized grade with D90 below 20 µm is commonly specified because larger crystals settle more rapidly and form hard-pack sediment that cannot be resuspended. If the distribution is broad, Ostwald ripening can progressively coarsen the suspension during storage at controlled room temperature. For tablets and capsules, particle size influences blend homogeneity and dissolution; a D90 below 150 µm is a typical release limit for standard oral grades, while low-dose direct compression formulas may require a D90 below 75 µm to ensure acceptable content uniformity. In premixes for medicated feed, the carrier and API particle size must be matched to avoid separation during bulk transportation; prolonged mixing of very fine prednisone with coarse corncob carriers can produce dead zones in mixers and assay variability exceeding 10% RSD. The acceptable particle-size range is therefore not a single pharmacopeial value but a formulation-specific range derived from blending studies and confirmed by USP <905> uniformity of dosage units where applicable.
| Parameter | Non-sterile oral/powder grade | Low-endotoxin parenteral grade | Reference method |
|---|---|---|---|
| Appearance | White to almost white crystalline powder | White to almost white crystalline powder | Visual / Ph.Eur. 2.2.1 |
| Assay | 97.0%–102.0% on dried basis | 97.0%–102.0% on dried basis | USP Prednisone monograph, HPLC |
| Specific optical rotation | +167° to +175° | +167° to +175° | Ph.Eur. Prednisone monograph |
| Loss on drying | ≤1.0% | ≤1.0% | USP <731> / Ph.Eur. 2.2.32 |
| Residue on ignition | ≤0.1% | ≤0.1% | USP <281> / Ph.Eur. 2.4.16 |
| Particle size D90 | ≤150 µm for direct compression; ≤75 µm for low-dose blends | ≤20 µm for suspension injectables | Laser diffraction USP <429> |
| Bacterial endotoxins | Not specified | ≤0.5 EU/mg vendor limit | USP <85> |
| Sterility | Not specified | Meets sterility test for injectables | USP <71> |
Medicated feed premixes containing prednisone are produced as low-concentration adsorption blends on a carrier such as ground corncob, wheat middlings, or lactose; the process typically uses a tumble blender operated at 60%–70% of gross capacity to avoid dead zones. The API is often pre-milled to a D90 below 75 µm and granulated or dry-blended with a carrier to a target assay of 1–10 mg/g. Mixing time is validated by sampling at least 10 positions per batch; the coefficient of variation should remain below 5% RSD. Carryover in feed mills is controlled with flush batches after production. In food-producing animals, use of prednisone is subject to extralabel drug use rules under 21 CFR 530 and requires a valid veterinarian-client-patient relationship; the withdrawal period is not the same as approved production drugs and must be extended based on the species and dose. Published data for this specific configuration is limited.
Injectable and ophthalmic dosage forms impose additional constraints beyond assay and impurity limits. Low endotoxin API is not synonymous with sterile API. A low-endotoxin grade is manufactured under controlled water and environmental conditions to reduce gram-negative bacterial load, but it may still contain viable organisms; terminal sterilization or aseptic processing of the finished product is required to meet USP <71>. Dry heat sterilization of prednisone powder can be destructive to the 17-hydroxyketone side chain, so suppliers of sterile prednisone typically rely on aseptic processing or a validated irradiation cycle. The chosen sterilization or aseptic route must be evaluated against forced degradation data; appearance of prednisolone and other related substances above the accepted limit requires rejection. For parenteral suspensions, viscosity, particle size, and syringeability are controlled with a 21-gauge needle as an in-process test; clogging and hard caking are failure modes associated with unmicronized prednisone. Finished injections are also tested for particulate matter under USP <788>, and the packaging must maintain sterility under the assigned shelf life. Production of sterile veterinary injectables from non-sterile prednisone on the purchaser's site is not permitted unless the facility holds validated terminal sterilization capacity and the API supplier's microbial burden is controlled to the terminal sterilization kill calculation.
Aqueous prednisone formulations are generally suspensions rather than true solutions because the free base solubility is approximately 0.12 mg/mL at 25 °C. In hydroalcoholic and cyclodextrin-containing vehicles, solution stability is governed by oxidative degradation of the 17,21-dihydroxyketone side chain and pH-dependent hydrolysis. Trace metal ions accelerate oxidation; nitrogen overlay and edetate disodium are typical manufacturing controls. pH is usually maintained in an acidic range because alkaline conditions promote degradation. For oral solutions, the finished product is packaged in amber glass or opaque plastic and stored below 25 °C; the precise formulation must be supported by stability-indicating HPLC. For injectable solutions requiring a true solution, only soluble esters such as prednisolone sodium phosphate or dexamethasone sodium phosphate are generally used; prednisone free base is not suitable for a simple aqueous injection solution. The main degradation route in solid prednisone products is hydrolytic and oxidative modification of the 17,21-dihydroxyketone side chain. Free moisture above 1.0% and storage above 30 °C accelerate the appearance of related substances. Excipient compatibility studies should evaluate reducing sugars, alkaline lubricants, and moisture-containing binders; these can increase related-substance formation. The API should be stored in sealed polyethylene-lined aluminum or HDPE containers with desiccant when relative humidity exceeds 60%.
Prednisone differs from prednisolone by the C-11 functional group: prednisone is the 11-keto analog, while prednisolone is the 11β-hydroxyl analog. In dogs, horses, and most mammalian species, prednisone is efficiently converted to prednisolone by hepatic 11β-hydroxysteroid dehydrogenase, giving similar anti-inflammatory activity. In cats, the conversion is less efficient, so clinicians and formulation developers often specify prednisolone as the direct active entity. Relative anti-inflammatory potency is commonly expressed against hydrocortisone: prednisone and prednisolone are assigned a value of 4, while dexamethasone is assigned 25–30. Mineralocorticoid activity is low for prednisone and prednisolone and negligible for dexamethasone. The solubility and salt-formation profile also differs: prednisone is most frequently used as the free base in oral solid and suspension forms, while prednisolone and dexamethasone are available as acetate, phosphate, or sodium succinate derivatives with higher aqueous solubility. This chemical difference determines which dosage forms are feasible without complex formulation approaches.
| Attribute | Prednisone | Prednisolone | Dexamethasone |
|---|---|---|---|
| C-11 functionality | 11-keto | 11β-hydroxyl | 9α-fluoro, 11β-hydroxyl |
| Relative anti-inflammatory potency vs hydrocortisone | 4 | 4 | 25–30 |
| Mineralocorticoid activity | Low | Low | Negligible |
| Oral conversion species dependence | Requires hepatic conversion to prednisolone; limited in cats | Directly active as prednisolone | Directly active; high potency |
| Typical API salt/base forms | Prednisone free base | Prednisolone base, acetate, sodium phosphate | Dexamethasone base, sodium phosphate, acetate |
The choice of prednisone base for a given veterinary product is therefore driven by target species, route, and solubility. A dosage form developer cannot simply substitute prednisolone on an equal mass basis because potency and species conversion differences require dose adjustment. Product-grade selection must be written into the submission dossier with the vendor's validated particle-size, endotoxin, and stability data attached to the relevant pharmacopeial and VICH compliance statements.
