| HS Code | 793488 |
| Product Name | Jiuhuang Powder Veterinary Grade API |
| Api Form | Powder |
| Product Class | Veterinary Active Pharmaceutical Ingredient (API) |
| Source Extract Base | Traditional Chinese botanical formulation known as Jiuhuang |
| Number Of Active Components | Nine-component herbal complex |
| Marker Compound Class | Flavonoids, alkaloids, anthraquinones, and polyphenolic acids |
| Molecular Formula | Mixture; no single molecular formula |
| Molecular Weight | Mixture; no single molecular weight |
| Appearance | Brownish-yellow fine powder |
| Odor | Characteristic, slightly aromatic herbal odor |
| Bulk Density | 0.40 to 0.70 g/mL |
| Solubility | Slightly soluble in water; partially soluble in dilute ethanol; forms a suspension |
| Ph 1 W V Aqueous Dispersion | 4.0 to 6.0 |
| Residual Solvents | Complies with applicable veterinary API residual solvent limits |
| Microbial Limits | Total viable aerobic count ≤ 10^5 CFU/g; yeasts and molds ≤ 10^3 CFU/g; Salmonella absent in 25 g; E. coli absent in 1 g |
| Storage Conditions | Sealed, cool, dry, ventilated, and protected from light |
| Shelf Life | 24 months under recommended storage conditions |
| Package Specifications | 1 kg, 5 kg, 10 kg, and 25 kg sealed inner packages |
| Target Animals | Poultry, pigs, cattle, sheep, goats, rabbits, fish, and companion animals depending on final formulation |
| Finished Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, and Solutions |
| Indications Function | Antibacterial, anti-inflammatory, heat-clearing, and detoxifying; supports therapy for enteritis, respiratory infections, and immune regulation |
| Recommended Dosage Range | Dependent on animal species, final formulation, and veterinary instruction |
| Combination Suitability | Can be compounded with approved veterinary excipients and APIs under GMP conditions |
| Regulatory Quality Compliance | Veterinary grade; manufactured under GMP and meets applicable enterprise veterinary pharmacopoeia standards |
| Contraindications Warnings | Use under veterinary supervision; avoid in animals with confirmed allergy to herbal ingredients |
As an accredited Jiuhuang Powder 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 aluminum foil bags with PE liner, 25 kg per fiber drum, for veterinary-grade Jiuhuang Powder API. |
| Container Loading (20′ FCL) | 20′ FCL container loading for Jiuhuang Powder veterinary API: sealed, dry, ventilated packaging in drums/cartons, safe for tablets, injections, capsules, powders, granules, premix, solutions. |
| Shipping | Ships worldwide in sealed, moisture-proof, tamper-evident packaging to preserve purity and stability. Veterinary-grade API requires hazmat compliance and temperature-controlled handling where necessary. Export documents, SDS, and origin certificates included. Secure, traceable courier with insulated cooling options available. Delivery time varies by destination and customs clearance. |
| Storage | Store in a cool, dry, well-ventilated area, protected from direct sunlight and excessive moisture. Keep the container tightly sealed when not in use. Avoid temperatures above 25°C and freezing, as stability may be affected. Follow veterinary guidelines for safe handling, and store away from feed, food, and out of reach of children and animals. |
| Shelf Life | Shelf life: 24 months from manufacture date when stored unopened in a cool, dry place, protected from light. |
During oral tablet production, Jiuhuang Powder Veterinary Grade API is specified as a multi-component botanical powder with a loss on drying limit of ≤5.0% before blending and a minimum of 90% passing an 80-mesh stainless steel sieve per ISO 3310-1:2016. Batches with moisture above 6.5% exhibit sticking and picking on rotary tablet presses fitted with 10 mm flat-faced bevel-edge punches, particularly when precompression force is set below 8 kN and turret speed exceeds 45 rpm. The API is pre-dried in a fluid-bed dryer at 55°C inlet air temperature until the loss on drying is ≤5.0%. Direct compression blends use microcrystalline cellulose at 30–40 wt%, crospovidone at 2–4 wt%, and magnesium stearate at 0.5–1.0 wt%. Main compression force is maintained between 18 kN and 25 kN to achieve tablet hardness of 60–90 N. Ejection force above 1500 N indicates insufficient lubrication, and magnesium stearate is then adjusted upward within the stated range. Over-lubrication above 1.5 wt% reduces tablet hardness and extends disintegration time beyond 30 min. Friability is required to remain ≤1.0% per USP <1216>. Dissolution is measured by USP <711> Apparatus II at 50 rpm in 900 mL of 0.1 N hydrochloric acid at 37°C ± 0.5°C. Release of the selected marker compound at 45 min is acceptable only when tablet porosity exceeds 18%. At relative humidity above 60%, pre-drying is required before sieve classification because the powder bridges over screen openings and creates assay bias in the undersize fraction.
Parenteral preparations derived from Jiuhuang Powder Veterinary Grade API are manufactured by reconstituting the API in Water for Injection at 40°C ± 2°C under a nitrogen purge. Headspace oxygen is controlled below 2.0% to limit oxidative degradation of extract fractions. The suspension is clarified through a 0.45 μm polyethersulfone filter, then passed through a 0.22 μm sterilizing-grade filter before filling into Type I glass vials. When turbidity is high, a glass-fiber prefilter is inserted upstream of the sterilizing filter, and differential pressure across the sterilizing membrane is held below 15 psi to prevent particle shedding. Pre-filtration bioburden is controlled below 10 CFU/100 mL per USP <61>, and endotoxin is controlled below 0.25 EU/mL per USP <85>. Terminal sterilization at 121°C for 15 min yields an F0 value of ≥8.0. The pH is held between 5.5 and 6.5 with citrate buffer because weakly basic alkaloid-type fractions precipitate under alkaline processing. HPLC assay of the marker compound after terminal sterilization is required because published stability data for this specific extract configuration is limited. Particulate matter must meet USP <788> limits for small-volume injections: ≤6000 particles/container ≥10 μm and ≤600 particles/container ≥25 μm after 24 h at 25°C.
For drinking-water administration in poultry and swine, the API is converted to a dispersible granule by high-shear wet granulation rather than dry blending. Top-spray fluid-bed drying at inlet air 60–70°C reduces residual moisture to ≤4.0% per USP <731>. The binder is povidone K30 at 5 wt% of the dry formula, dissolved in purified water. Impeller speed in the high-shear granulator is held at 200–300 rpm, with chopper speed 1500–2500 rpm, until granule size distribution reaches D50 250–500 μm. Fumed silica at 0.3–0.8 wt% is added after drying to bring the angle of repose below 35° and bulk density to 0.50–0.70 g/mL. Final use rate in drinking water is typically 0.5–1.0 g/L. In hard water with total hardness above 300 mg/L CaCO₃, visible precipitation of weakly ionized extract fractions occurs unless an acidifying agent or citrate buffer maintains pH 6.0–6.8. Dispersion is tested by adding 1.0 g of granules to 900 mL of water at 25°C with paddle stirring at 50 rpm; complete dispersion should occur within 15 min. The granule is packaged in multi-layer foil sachets with a moisture barrier below 0.1 g/m²/day to prevent caking at storage above 25°C.
Two-stage dilution is employed for feed premix manufacture using Jiuhuang Powder Veterinary Grade API. The first stage mixes the API 1:10 with a carrier of ground rice hulls and light calcium carbonate in a ribbon blender at 20–25 rpm for 15 min. The second stage dilutes the intermediate to final inclusion rates between 0.2 kg and 1.0 kg of API per metric ton of complete feed. Acceptance is based on marker content uniformity with a coefficient of variation below 5.0% across 10 sampling points per ISO 6497:2002. Carryover in discharge lines is controlled by flushing with 5 kg of clean carrier after each batch when the assay indicates carryover above 1.0% of batch mass. Feed hygiene follows EU Regulation 183/2005/EC, and finished premix moisture is maintained below 10.0% to limit fungal growth. Carriers with lipid content above 4.0% reduce flow and increase segregation during auger transfer, so defatted carriers are preferred. Ribbon blender discharge gates are opened only after the full mixing time and after the mixer has reached a uniform amperage plateau, because the API tends to concentrate in the center dead zone when loading is uneven.
| Parameter | Test method / standard | Criterion |
|---|---|---|
| Tablet friability | USP <1216> | ≤1.0% |
| Oral granule loss on drying | USP <731> | ≤4.0% |
| Injection particulate matter, small-volume | USP <788> | ≤6000 particles/container ≥10 μm; ≤600 particles/container ≥25 μm |
| Premix marker content uniformity | ISO 6497:2002 | CV ≤5.0% across 10 sample points |
| Capsule fill weight variation | USP <905> | AV ≤15.0 |
| Sterile dry powder residual moisture | USP <921> | ≤3.0% |
Capsule filling of the API for companion animal oral dosage forms requires granulation with low moisture and a high-density flow aid. Encapsulation on an intermittent tamping-type capsule filler with pin settings of 3–5 mm and tamping force 50–100 N produces acceptable fill weight when the granulate bulk density is 0.45–0.60 g/mL. Hausner ratio is maintained between 1.25 and 1.35. The formula includes fumed silica at 0.5–1.5 wt% and pregelatinized starch at 5–10 wt%. Filled capsules typically use size 3 or size 4 shell. Shell moisture equilibration is performed at 35–45% RH and 15–25°C. Fill weight variation is tested per USP <905>; the acceptance value is ≤15.0. Capsule moisture content after equilibration is controlled at ≤4.0% because higher moisture causes shell embrittlement and cracking in cold climates. Dissolution is tested by USP <711> Apparatus I at 100 rpm in 900 mL of 0.1 N hydrochloric acid at 37°C ± 0.5°C, with more than 75% release of marker at 45 min. Avoid combination with hygroscopic filler levels above 10 wt% because moisture transfer into the shell accelerates cross-linking and retards release.
Dry powder injection presentations of Jiuhuang Powder Veterinary Grade API are filled as 500 mg or 1000 mg volumes into 10 mL Type I tubular vials under ISO 14644-1:2015 Class 5 conditions. The powder is freeze-dried from aqueous extract solution at a fill depth of 5–8 mm. Collapse temperature is determined by freeze-dry microscopy before cycle design; primary drying shelf temperature is set 2–4°C below the measured collapse temperature. Residual moisture after lyophilization is tested per USP <921> and controlled at ≤3.0%. Reconstitution time is measured by injecting 10 mL of sterile Water for Injection and swirling; complete reconstitution should occur in ≤90 s. The reconstituted solution must meet USP <788> particulate limits and USP <85> endotoxin limit before administration. Published data for this specific lyophilized herbal formulation is limited; therefore, cycle parameters are confirmed by pilot-scale lyophilization runs in a freeze-dryer with shelf area 0.5–1.0 m².
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Jiuhuang Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a controlled botanical-derived active pharmaceutical ingredient supplied as a free-flowing powder for further pharmaceutical processing. The powder is not a finished dosage form and is not intended for direct administration without validated formulation steps. The designation indicates that the material may be incorporated into multiple veterinary presentations, provided that the downstream process is matched to the route of administration. Model identifiers are manufacturer-specific and are not assigned by any pharmacopoeial monograph; the product should therefore be addressed by its supplied certificate of analysis, batch number, and veterinary master file reference.
The specification framework is based on identity, purity, particulate control, and microbial quality. Because the product contains multiple chemical constituents, release testing cannot rely on a single assay alone. The analytical profile typically combines chromatographic fingerprinting, marker-substance quantification, loss on drying, ash, heavy metals, microbial enumeration, residual solvents, and particle-size distribution. The following matrix summarizes the core release parameters and the methods most often referenced for veterinary-grade botanical APIs.
| Parameter | Reference method | Manufacturing relevance |
|---|---|---|
| Loss on drying | USP <731> | Residual moisture affects flow, microbial stability, tablet hardness, and capsule filling. |
| Total ash and acid-insoluble ash | Ph. Eur. 2.4.16 or USP <561> | Controls non-pharmacological mineral contamination and silicate matter. |
| Heavy metals | USP <231> or USP <233> | Controls Pb, Cd, As, and Hg; injection grades require lower limits. |
| Microbial enumeration | USP <61> | Confirms total aerobic microbial count and yeast/mold count for non-sterile forms. |
| Specified organisms | USP <62> | Confirms absence of objectionable organisms such as Escherichia coli and Salmonella. |
| Residual solvents | USP <467> | Required when extraction, precipitation, or recrystallization solvents are used in manufacture. |
| Pesticide residues | USP <561> | Addresses contamination from botanical raw materials. |
| Particle-size distribution | ISO 13320 or USP <429> | Determines flow, blend uniformity, dissolution rate, and injection clarity. |
| Bulk and tapped density | USP <616> | Supports capsule fill weight and tablet die filling calculations. |
| Bacterial endotoxins | USP <85> | Required for injectable solution development and terminal sterilization validation. |
Acceptance limits are not fixed by a harmonized monograph and must be taken from the veterinary marketing authorization file or the supplier’s certificate of analysis. Values commonly referenced for botanical APIs include heavy metals not exceeding 20 ppm as lead when tested by USP <231> or USP <233>, but the Jiuhuang Powder specification may differ by supplier and region. Published data for this specific configuration is limited; therefore, product-specific limits should not be assumed from class-level pharmacopoeial defaults.
For particle-size distribution, dry dispersion on a laser diffraction instrument at 0.5 bar to 2.0 bar is common, but the dispersion pressure should be optimized to avoid particle fracture. The D10, D50, and D90 values should be reported, not only the D50, because oversized material controls injection clarity and tablet surface defects.
The critical release parameters differ by intended dosage form. For tablets, capsules, powders, granules, and premix, the most pressing controls are particle-size distribution, bulk density, and moisture. For injectable solutions, the emphasis shifts to bioburden, bacterial endotoxins, particulate matter after dissolution, and compatibility with terminal sterilization or aseptic filtration.
The raw API is not sterile and is not automatically suitable for injection. If the product is intended for a parenteral solution, the formulated drug product must meet sterility under USP <71>, bacterial endotoxins under USP <85>, and particulate matter under USP <788> after reconstitution. The powder itself should demonstrate low bioburden under USP <61> and absence of specified organisms under USP <62>. A bacterial endotoxin specification for the API is necessary because subsequent depyrogenation of a botanical powder is difficult without altering the multi-component composition.
On production-scale filtration lines, botanical APIs containing polysaccharide or glycoprotein fractions can form colloidal aggregates that blind 0.22 µm sterilizing-grade membranes. Filter capacity testing at constant pressure should be performed before scale-up. If the membrane area is undersized, the batch may require staged clarification through 1.2 µm and 0.45 µm prefilters. Filter adsorption is another risk because hydrophobic membrane polymers may remove active polyphenolic constituents and change the chromatographic fingerprint. Compatibility with the actual membrane and housing material should be established using the production-scale filter type.
Solubility in water for injection, propylene glycol, and glycerin-water systems should be screened before selecting the manufacturing route. Published solubility data for this specific configuration is limited. If the solution is heat-stable, terminal steam sterilization at 121 °C for 15 min may be evaluated; however, polyphenol-rich botanical extracts can show pH drift, color darkening, or precipitation during thermal cycling. If aseptic filtration is selected, the formulation must be sufficiently dissolved or suspended to pass through the chosen membrane, and the product must be filled under aseptic conditions.
For parenteral use, the bacterial endotoxin limit is dose-dependent and is calculated under USP <85>. A common calculation basis for intravenous veterinary products is 5 EU/kg of body weight per hour, but the product-specific value is derived from the maximum dose. If the API contains residual solvents, the injection form may require additional drying or solvent exchange to bring levels below VICH GL18 residual solvent limits. The presence of transition metal ions from raw material or equipment contact surfaces may promote oxidative degradation of phenolic constituents. For parenteral presentations, chelating agents should be evaluated only if compatibility and pharmacological acceptability support their use.
When the API is processed into tablets, capsules, powders, granules, and premix, the dry powder characteristics govern the manufacturing route. Botanical powders often exhibit poor flow and segregation risk; therefore, direct compression is not assumed. In a high-shear granulator, the binder solution should be controlled by impeller and chopper speed, and the wet mass is commonly screened through a 1.0 mm sieve before drying. Fluid-bed drying for botanical granulates is often conducted at inlet air temperatures of 50 °C to 70 °C, with a control window as narrow as ±5 °C around the target temperature for heat-sensitive marker constituents. The upper limit for Jiuhuang Powder must be supported by thermal stability data. Drying to a target loss-on-drying range is more important than a fixed time because batch-to-batch moisture variation affects tablet hardness and dissolution.
Blend uniformity is a significant source of batch failure. The API should be geometrically diluted with excipient to avoid segregation, and blend samples should be tested for marker content before compression. For tablets, content uniformity testing under USP <905> should be included in process validation. For low-dose tablets, the active particle size should be controlled relative to tablet weight; a D90 above 250 µm may increase content uniformity defects. Sieving through a 0.250 mm screen may be necessary for tableting, while a coarser fraction is more acceptable in premix and granule formulations where the dose is dispersed in a feed matrix.
Capsule filling on tamping-pin or dosator machines requires a free-flowing blend. If the API exhibits electrostatic adhesion, the filling suite can be maintained at 40–55% RH, but only if moisture uptake studies demonstrate no adverse effect on chemical stability. The powder should not be excessively adhesive to the dosator or tamping pins. A rotary tablet press with a forced feeder may generate additional fines if the carrier granules are brittle. Tablet friability should be monitored according to USP <1216> or Ph. Eur. 2.9.7.
Oral solutions and suspensions present a different set of constraints. The API may be dissolved in purified water with co-solvents, or suspended with a wetting agent. The solution pH should be selected to minimize hydrolysis of ester or glycosidic bonds in the marker constituents. If the powder contains insoluble cellulosic fragments, filtration through a 10 µm clarifying filter may be needed; however, sterile filtration should not be equated with chemical compatibility. Preservative systems should be tested for assay interference and preservative efficacy under USP <51>.
For medicated premix, mixing time and equipment type affect carryover and homogeneity. A ribbon blender with a fill level of 60–70% of gross volume is a common production configuration, but validation must be performed with the actual API concentration. The material should be added through a screen to break agglomerates. The homogeneity of the final premix should be confirmed by assay of a marker constituent. The carrier should be dried to a moisture content compatible with the API; free water above 10–12% can support mold growth and reduce blend uniformity.
Crude botanical powder is generally sold by botanical origin and macroscopic appearance, without a pharmacopoeial assay, residual solvent profile, or controlled particle-size distribution. Feed additive grade material may meet feed safety standards but does not routinely meet pharmaceutical microbial limits, heavy-metal ceilings, or injection-related endotoxin controls. Jiuhuang Powder Veterinary Grade API is intended for pharmaceutical processing and should be accompanied by a certificate of analysis showing identity, loss on drying, total ash, heavy metals, microbial enumeration, and specified particle-size parameters. The difference is therefore not only particle size but the completeness of the quality file.
| Attribute | Jiuhuang Powder Veterinary Grade API | Crude botanical powder | Feed additive grade |
|---|---|---|---|
| Identity and assay | Chromatographic fingerprinting and marker quantification per supplier dossier | Often macroscopic or organoleptic only | May have feed-specific marker methods |
| Microbial control | Tested to USP <61>/USP <62> or equivalent | Uncontrolled bioburden common | May meet feed hygiene but not pharmaceutical limits |
| Particle-size distribution | Controlled by ISO 13320 or USP <429> | Variable depending on grinding | Usually coarse and not suitable for tableting |
| Residual solvents | Tested to USP <467> when extraction solvents are used | Not routinely tested | Not routinely tested |
| Heavy metals | Specified as Pb, Cd, As, and Hg | Not routinely tested | May have regional feed limits |
| Documentation | Certificate of analysis, stability data, veterinary master file reference available | Limited to bill of lading or botanical certificate | Feed safety statement only |
Compared with chemically defined veterinary APIs, this product is a multi-component botanical matrix. Quality cannot be characterized by a single high-performance liquid chromatography assay alone; chromatographic fingerprinting and marker-substance quantification are required. This difference changes stability protocols, impurity profiling, and dissolution testing because multiple constituents may contribute to the pharmacological effect and to analytical interference. A change in the source region, harvest time, or extraction process may shift the fingerprint even when the total extractive content remains within specification.
Another difference is the absence of a universal model number. Commercial grades are often differentiated by sieve fraction, bulk density, extractable matter, and residual solvent class rather than a harmonized code. A supplier may designate a tablet grade as 80 mesh and a premix grade as 40 mesh, but these descriptors are not regulatory identifiers. The customer should request the supplier’s veterinary master file reference and the batch-specific certificate of analysis before using the powder in registered drug products.
Potency expression also differs from that of chemically defined APIs. Because the material is not a single chemical entity, potency is often expressed as content of one or more marker compounds per gram rather than as percentage of a pure active. This differs from chemically defined APIs such as oxytetracycline hydrochloride or ivermectin, where potency is expressed as a defined chemical assay. If a lot is labeled by total powder weight, the marker content should be printed on the certificate of analysis to enable accurate dose calculation in tablets and injectables.
Storage and retest boundaries should follow the supplier’s stability commitment. In the absence of product-specific data, protect the powder from moisture, light, and excessive heat. A common storage condition for botanical APIs is 25 °C at 60% RH in sealed polyethylene-lined fiber drums, but the assigned condition must be confirmed by long-term and accelerated studies according to VICH GL3 and VICH GL5. Published stability data for this specific configuration is limited.
The main process conflict in solid-dosage manufacture is between moisture and compression. Moisture above 5% may improve compactibility but reduce microbial stability; moisture below 2% may increase friability and electrostatic adhesion. The process window must be determined by factorial studies because published data for this specific configuration is limited. Similarly, in injectable manufacture, a clarifying filtration intended to reduce bioburden may remove active colloidal components and alter the chromatographic fingerprint; therefore, filter adsorption and product recovery should be included in the process design.
