| HS Code | 696540 |
| Product Name | Hydrocortisone Ointment Veterinary Grade API |
| Active Pharmaceutical Ingredient | Hydrocortisone |
| Grade | Veterinary Grade |
| Intended Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Appearance | White or practically white crystalline powder |
| Molecular Formula | C21H30O5 |
| Molecular Weight | 362.46 g/mol |
| Cas Number | 50-23-7 |
| Melting Range | Approximately 212°C to 222°C |
| Solubility | Practically insoluble in water; soluble in ethanol and acetone |
| Assay | 97.0% to 102.0% on dried basis |
| Storage Conditions | Store in airtight containers, protected from light, at controlled room temperature |
| Shelf Life | Typically 36 months under recommended storage conditions |
| Pharmacological Category | Corticosteroid anti-inflammatory agent |
As an accredited Hydrocortisone Ointment 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 | Packed in double polyethylene-lined fibre drums, securely sealed and labelled, with net quantity of 25 kg per drum. |
| Container Loading (20′ FCL) | 20′ FCL shipment of veterinary-grade Hydrocortisone API, securely packed for tablets, injections, capsules, powders, granules, premix, and solutions. |
| Shipping | Shipping: Supplied in sealed, light-resistant, food-grade drums or bags with tamper-evident seals. Ambient temperature transport acceptable; avoid humidity and direct sunlight. Full documentation, Certificates of Analysis, and Safety Data Sheets accompany each shipment. For international orders, export packaging complies with ISO standards and customs regulations. |
| Storage | Store in a well-closed, light-resistant container in a cool, dry place at controlled room temperature (20–25°C, excursions 15–30°C permitted). Protect from moisture, direct sunlight, and freezing. Keep away from strong oxidizers. Ensure container remains tightly sealed when not in use. |
| Shelf Life | Shelf life is typically 24 months when stored in well-closed containers, protected from light, moisture, and heat. |
Compressed tablet manufacture for adrenal supplementation in dogs uses hydrocortisone at 5 mg, 10 mg, or 20 mg per unit dose, producing an API load of 5.0–20.0 wt% in a 100–150 mg core tablet. Where the supplied hydrocortisone grade is an ointment-grade micronized powder with bulk density below 0.40 g/cm³, direct compression without precompaction develops poor powder flow on rotary presses and unacceptably high weight variation; slugging or dry granulation is therefore introduced before final compression. Blend uniformity is controlled under USP 905, dissolution under USP 711, assay by HPLC under USP 621, and friability under USP 1216. A direct compression route typically disperses the API in a 1:5 first-pass premix with lactose monohydrate through a 250 µm stainless-steel screen, then combines the premix with microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate in a V-blender at 60% fill volume and 15–25 rpm for 10–15 minutes. Final compression on a rotary tablet press with 10 mm round D-tooling at 7–12 kN compression force targets hardness 4–7 kp and friability ≤0.8%. When wet granulation is required for poor-flowing API lots, povidone K30 at 3–5 wt% of the dry granule mass is applied as an aqueous binder, followed by fluid-bed drying at inlet 55–65°C to final moisture 1.0–2.0%. Capsule filling for dogs requiring 2 mg, 5 mg, or 10 mg strengths uses hard gelatin or hypromellose capsules size 3 or 4, with fill weights of 100–180 mg and API load 1.1–10.0 wt%. Terminal product types are uncoated tablets and powder-filled capsules for oral administration in canine hypoadrenocorticism.
| Parameter | Direct compression | Wet granulation |
| API load | 5–20 wt% | 3.3–13.3 wt% |
| Required API particle size | D90 ≤ 30 µm | D90 ≤ 50 µm |
| Blend time | 10–15 min | 5–8 min dry stage + 2–4 min wet stage |
| Final moisture | ≤2.0% | 1.0–2.0% |
| Tablet hardness | 4–7 kp | 5–8 kp |
| Primary standard | USP 905, USP 1216 | USP 711, USP 621 |
In lyophilized hydrocortisone sodium succinate production for acute adrenal crisis treatment, the injectable-grade derivative is dissolved in Water for Injection at 50 mg/mL hydrocortisone equivalent, with mannitol at 20–40 mg/mL as a crystalline bulking agent. This yields 5.0% w/v API in the pre-lyophilization solution and 60–75 wt% API in the dried cake, depending on buffer mass. The solution is sterile-filtered through a 0.22 µm PVDF membrane before filling into 2 mL or 5 mL Type I borosilicate glass vials. Lyophilization is programmed with a freezing ramp to −40°C, primary drying at −25°C and 0.2–0.4 mbar, and secondary drying at 25°C and 0.03 mbar. Batch acceptance follows USP 1 for injections, USP 85 for bacterial endotoxins, USP 788 for subvisible particulate matter, and 21 CFR 211.165 for finished product testing. Residual solvent limits follow VICH GL18(r), and elemental impurity controls apply under ICH Q3D. Reconstitution to 2 mL produces a 50 mg/mL injectable solution used as an intravenous bolus in emergency veterinary practice. Terminal product types are lyophilized cakes in single-dose vials and the reconstituted solution administered by intravenous or intramuscular injection.
Petrolatum-based ointments for canine dermatological inflammation incorporate micronized hydrocortisone at 0.5 wt%, 1.0 wt%, or 2.5 wt% into a heated anhydrous base containing white petrolatum, mineral oil, and, where specified, lanolin alcohols. Micronization to D90 ≤ 50 µm is required because particles larger than 75 µm produce grittiness and nonuniform drug distribution during tube filling. The ointment-grade API is levigated with mineral oil at a 1:1 to 1:2 ratio before incorporation into the base at 55–60°C. A three-roll mill with a 15–25 µm gap is used to disperse residual agglomerates; the milled mass is then cooled from 60°C to 25°C at 0.5°C/min to prevent oil phase separation. Viscosity at 25°C is maintained between 100,000–200,000 cP to allow filling into laminate tubes without syneresis. Preservative effectiveness is challenge-tested under USP 51, with microbial enumeration under USP 61 and objectionable organism screening under USP 62. Finished ointment assay and content uniformity follow USP 621 and USP 905 where applicable. Terminal product types include 15 g and 30 g laminate tubes and 454 g veterinary clinic jars.
| Test category | Standard designation | Test objective |
| Microbial limits | USP 61, USP 62 | Total aerobic count, absence of Staphyloccocus aureus and Pseudomonas aeruginosa |
| Antimicrobial effectiveness | USP 51 | Preservative activity against compendial challenge organisms |
| Particle size | Internal specification D90 ≤ 50 µm | Dermal grittiness control |
| Assay | USP 621 | Hydrocortisone label claim |
| Elemental impurities | ICH Q3D | Class 1 and Class 2A metal limits |
| Residual solvents | VICH GL18(r) | Compendial solvent limits |
The preparation of weight-banded hydrocortisone oral powders for dogs under 10 kg requires geometric dilution with lactose monohydrate at ratios from 1:10 to 1:100 to achieve final strengths of 0.1–1.0 mg/g. A low-shear tumble blender operated at 60% fill volume and 15–25 rpm for 10–15 minutes disperses the API; the blend is screened through a 500 µm sieve to remove lumps. Sachet fill weights of 500 mg or 1 g are controlled to ±5% on an auger filler, and segregation is monitored by sampling 10 locations across the blender. Granulation, when required for dusty powders, uses povidone K30 at 3–5 wt% of the dry blend mass in purified water, fluid-bed drying at inlet 55–65°C, and final moisture ≤2.0%. For manufactured batch release under 21 CFR 211, dose uniformity is tested per USP 905 and assay per USP 621; for extemporaneous dispensing, USP 795 governs nonsterile compounding. Terminal product types are unit-dose powder packets and oral granules in sachets for dose titration below available tablet strengths.
When a hydrocortisone API-excipient premix intermediate is specified for direct compression and capsule filling, the first manufacturing objective is the elimination of undispersed drug-rich agglomerates before final dilution. A premix is commonly prepared at 2.0–10.0 wt% hydrocortisone in a carrier of lactose monohydrate and pregelatinized starch, then added to the final blend at 15–35 wt% to reach the target unit dose. The low-dose premix is screened through a 250 µm stainless-steel screen after a 1:5 first-pass blend, then reblended for 10–15 minutes in a low-shear tumble mixer at 60% fill volume. The intermediate is packaged in double polyethylene-lined fiber drums under nitrogen purge to limit moisture uptake below 2.0% and to maintain flowability. Incoming API is controlled under 21 CFR 211.84, in-process sampling under 21 CFR 211.110, and final blend uniformity under USP 905. Terminal product type is the premix intermediate itself, subsequently consumed on tablet and capsule manufacturing lines for low-dose veterinary oral products.
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Hydrocortisone Ointment Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions refers to the non-esterified glucocorticoid hydrocortisone, CAS 50-23-7, chemical name 11β,17α,21-trihydroxypregn-4-ene-3,20-dione, molecular formula C21H30O5, and relative molecular mass 362.46. The material is supplied as a white or almost white crystalline powder and is controlled against the relevant pharmacopoeial monograph for hydrocortisone, with an assay acceptance range of 97.0%–102.0% on the dried basis. The product designation does not indicate a finished ointment; rather, it identifies a veterinary-grade active pharmaceutical ingredient whose particle-size distribution, polymorph identity, residual solvent profile, and endotoxin controls are suitable for incorporation into multiple veterinary dosage forms including tablets, capsules, injectable suspensions, powders, granules, premixes, and semisolid preparations.
The API is manufactured under current good manufacturing practice for active substances as described in ICH Q7 and is distributed in manufacturer-assigned particle-size grades. The standard-milled grade is intended for oral solids and feed premixes, while the micronized grade is intended for ointments and aqueous parenteral suspensions. Pharmacopoeial identification includes infrared absorption spectrophotometry against hydrocortisone chemical reference substance and specific rotation between +150° and +156°, determined on the dried substance. The API is practically insoluble in water, sparingly soluble in acetone, and slightly soluble in ethanol 96%, a solubility profile that directly governs formulation selection for each route of administration.
In small-animal and food-animal practice, the choice among hydrocortisone, prednisolone, and dexamethasone is based on glucocorticoid potency, mineralocorticoid activity, receptor-binding duration, and species-specific metabolism. Hydrocortisone is assigned a relative glucocorticoid potency of 1, prednisolone approximately 4, and dexamethasone approximately 25; unlike the fluorinated corticosteroid dexamethasone, hydrocortisone retains clinically relevant mineralocorticoid activity, which influences electrolyte handling and fluid retention in mammalian patients. In cattle and horses, hydrocortisone has a shorter biological half-life than dexamethasone, making it less suitable for long-duration anti-inflammatory protocols but reducing the duration of adrenal suppression when single-dose or short-course therapy is intended. Published data for species-specific receptor occupancy in food-producing animals is limited; therapeutic selection should therefore follow the approved veterinary medicinal product indications rather than in-vitro potency values alone.
For the unesterified base, the impurity profile is controlled by liquid chromatography using a pharmacopoeial method equivalent to USP 621. Typical acceptance limits for unspecified individual impurities are not more than 0.5%, and total impurities not more than 1.0%; the specific cortisone-related impurity limit is set at not more than 0.5% in many registration dossiers. Loss on drying is not more than 0.5%, and residue on ignition is not more than 0.1%, tested according to USP 731 and USP 281, respectively. Residual solvent levels are controlled under ICH Q3C(R8) criteria; where acetone or ethanol is used during crystallization, class 3 limits of not more than 5000 ppm apply. Elemental impurities are controlled on a risk basis under ICH Q3D(R2) as implemented for veterinary active substances, with the final limits determined by the route of administration and maximum daily dose in the target species.
| Parameter | Acceptance criterion | Method or reference standard |
|---|---|---|
| Appearance | White or almost white crystalline powder | Visual inspection against compendial description |
| Specific rotation | +150° to +156° | Polarimetry on dried substance |
| Assay | 97.0%–102.0% | HPLC, USP 621 |
| Unspecified individual impurity | ≤ 0.5% | HPLC area normalization |
| Total impurities | ≤ 1.0% | HPLC area normalization |
| Cortisone-related impurity | ≤ 0.5% | HPLC area normalization |
| Loss on drying | ≤ 0.5% | USP 731 |
| Residue on ignition | ≤ 0.1% | USP 281 |
| Residual ethanol or acetone | ≤ 5000 ppm each | Headspace GC, ICH Q3C(R8) |
| Particle size, micronized grade | D90 ≤ 30 µm | Laser diffraction, USP 429 |
| Particle size, standard-milled grade | D90 ≤ 150 µm | Laser diffraction, USP 429 |
Micronization is performed with a spiral jet mill using venturi pressure 0.8–1.2 MPa and grinding pressure 0.6–1.0 MPa, with the gas supply filtered through 0.2 µm membranes and dried to a dew point below -40 °C. The objective is a laser diffraction D90 of not more than 30 µm for ointment and aqueous suspension use, because larger primary crystals create grittiness and nonuniform drug distribution in semisolids. X-ray powder diffraction must confirm that the crystalline pattern matches the pharmacopoeial reference; micronization can introduce amorphous content and surface disorder. If amorphous content exceeds 5%, the material may recrystallize during storage in an ointment base, shifting particle size distribution and reducing physical stability. For oral powders and premixes, the standard-milled grade with D90 ≤ 150 µm is used to control segregation while maintaining flow.
Premix homogeneity studies on ribbon blenders show that hydrophobic APIs at low inclusion rates adhere to stainless steel surfaces when static charge is present. Granulation with mineral oil or pregelatinized starch at 2%–5% w/w reduces segregation and improves blend adhesion to the carrier. Sieving through a 500 µm aperture before blending removes agglomerates that would otherwise survive distribution in low-dose medicated feeds. Bulk density, tapped density, and compressibility index should be recorded for each milling campaign because shifts in these values alter metering accuracy in granulate filling and premix packaging lines.
Direct compression of hydrocortisone is limited by low bulk density and poor flow; production-scale tablet presses exhibit weight variability when the API fraction is high. Dry granulation by slugging or roller compaction is preferred for low-dose veterinary tablets. In wet granulation, the binder solution should be added until a final moisture of 2.0%–4.0% is achieved before drying; overwetting above 5.0% causes particle agglomeration and increases capping tendency in rotary presses. Diluents such as lactose monohydrate, microcrystalline cellulose, and pregelatinized starch are commonly used; excipients with high moisture content require pre-drying unless the formulation is explicitly developed for wet granulation. Tablet friability should be controlled below 1.0% when tested according to USP 1216, and content uniformity should meet USP 905 acceptance values for low-dosage veterinary products.
For injectable formulations, the unesterified base cannot be dissolved directly in water for injection because of its aqueous solubility below 0.3 mg/mL at 25 °C; aqueous suspensions therefore require a suspending agent such as sodium carboxymethylcellulose and a wetting agent. Terminal sterilization of a hydrocortisone suspension may alter particle size distribution and suspension viscosity if autoclaving is used; aseptic processing or validated sterile filtration of the vehicle is therefore evaluated. The API for parenteral use must meet a defined bacterial endotoxin specification derived from the final product dose; a typical starting API bioburden control point is not more than 100 CFU/g, with absence of specified indicator organisms. For solution-based injectables, co-solvent systems containing propylene glycol, ethanol, and benzyl alcohol can dissolve the base; however, dilution with aqueous media may precipitate hydrocortisone, and the solution pH must remain between 4.0 and 7.0 to limit degradation.
Hydrocortisone acetate differs from the base by substitution at the C-21 position with an acetyl group; the ester lowers water solubility further and produces a depot effect in otic and intra-articular suspensions. Hydrocortisone sodium succinate is freely soluble in water and is used for intravenous or intramuscular administration when rapid systemic availability is required. Unlike the acetate ester, the base does not require enzymatic hydrolysis for receptor activation and is therefore less dependent on esterase activity at the application site. Compared with prednisolone, hydrocortisone has a shorter duration of action and greater mineralocorticoid effect; compared with dexamethasone, it has lower anti-inflammatory potency and reduced suppression of the hypothalamic-pituitary-adrenal axis at equipment doses.
| Attribute | Hydrocortisone base | Hydrocortisone acetate | Hydrocortisone sodium succinate |
|---|---|---|---|
| Aqueous solubility | Practically insoluble | Practically insoluble | Freely soluble |
| Onset after parenteral administration | Slow | Slow depot | Rapid |
| Ester hydrolysis required | No | Yes | Yes |
| Primary formulation use | Oral solid, topical, ointment, premix | Otic, depot suspension, ointment | Intravenous, intramuscular |
| Mineralocorticoid effect relative to hydrocortisone | 1 | Approximately 1 after hydrolysis | Approximately 1 after hydrolysis |
Hydrocortisone is incorporated into feed premixes by geometric dilution and mixed in a double-cone or ribbon blender. Segregation occurs when the carrier particle size differs from the API by more than 10-fold; sieving to a comparable range before blending reduces content uniformity failure. Final coefficient of variation for finished premix blends should not exceed 5.0% as determined by sampling at 10 equally distributed locations. Light and oxidation can accelerate degradation; premix packaging should include light-resistant liners and desiccant when relative humidity exceeds 60%. In capsules, the base may be filled after dry granulation or slugging; lactose-based formulations should be protected from moisture ingress because hydrocortisone-containing powders can become compacted in hoppers under high humidity and cause interrupted auger flow in automatic capsule filling equipment.
Cleaning validation for multiproduct veterinary API facilities uses swab limits of 10 ppm if a toxicologically justified acceptance criterion derived from permitted daily exposure has not been established; hydrocortisone is a potent glucocorticoid and carryover into non-hormonal product lines must be controlled. The API is stable for 24 months in tight, light-resistant containers at 15–25 °C. Avoid contact with strong oxidizing agents and strong bases; alkaline cleavage at the C-17 side chain is a known degradation pathway. Operations at relative humidity above 60% require pre-drying before tabletting to maintain loss on drying below 0.5%. Published data for all species-specific veterinary dose configurations is limited; each finished product must be validated against its individual marketing authorization and target-species safety file.
